Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009039068

FEI Number

3009039068

Entity Name

HA2 MEDIZINTECHNIK GMBH

City/State/Country

Halberstadt Saxony-Anhalt, DE

Establishment Address

Am Bahndamm 11, Halberstadt Saxony-Anhalt 38820, DE

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

HA2 Medizintechnik GmbH (Owner Number: 10042677)

Owner / Operator Contact Address

Am Bahndamm 11, Halberstadt, DE-ST 38820, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NEEDLE, CONDUCTION, ANESTHETIC (W/WOINTRODUCER) Flex-Catch NT ACCESSORIES, CATHETER MultiCut Solo NEEDLE, CONDUCTION, ANESTHETIC (W/WOINTRODUCER) Eclipse Halo Venus Dormia front SonoPlex II INTRABEAM SMART Spherical Applicator 50 mm (diam.) INTRABEAM SMART Spherical Applicator 20 mm (diam.) INTRABEAM SMART Spherical Applicator 35 mm (diam.) INTRABEAM SMART Spherical Applicator 40 mm (diam.) INTRABEAM SMART Spherical Applicator 45 mm (diam.) INTRABEAM SMART Spherical Applicator 30 mm (diam.) INTRABEAM SMART Spherical Applicator 15 mm (diam.) INTRABEAM SMART Spherical Applicator 25 mm (diam.) Lyoplant Onlay SonoTAP NRFit Dermatome - Blades For Dermatome And Mucotome; Dermatome; Mucotome ELECTRODE, NEEDLE Anesthesia conduction kit Visumax Femtosecond Laser SPROTTE® STANDARD Syringe, piston Confida Brecker Guidewire GWBC30 Stimuplex® Onvision® Needle GERDX®-System LimFlow System MultiPulse HoPLUS SchurSign Tissue Marker MCL 31 Dermablate, Juliet LimFlow Vector Tubing Set Lyoplant Creos xenoprotect, Kontour Matrix, Zmatrix UltraTrack guidewire Apollo Meridian Slip NEEDLE, CONDUCTION, ANESTHETIC (W/WOINTRODUCER) LimFlow ARC Neuro Shield Fiber Optic for PLA Short blue Laser Surgery Fiber - Dental Bare Fiber 320?m Fiber Optic for PLA Short yellow Laser Surgery Fiber - Radial Emission 600?m Stopper Laser Surgery Fiber Dental Bare Fiber 200?m Fiber Optic for PLA Long yellow Fiber Optic for MRI blue Laser Surgery Fiber Chirurgie Bare Fiber 320?m Laser Surgery Fiber - Radial Emission 600?m Vein Laser Surgery Fiber - DiLAS® Laser Radial Venous Probe Laser Surgery Fiber - Radial Emission 400?m Stopper Fiber Optic for PLA Short green Laser Surgery Fiber - DiLAS® Laser Hemorrhoid Probe Laser Surgery Fiber - DiLAS® Laser Thyroid Probe Fiber Optic for PLA Long blue Laser Surgery Fiber - Radial Emission 400?m Fiber Optic for PLA Short red Corona 360 Fiber 600?m Fiber Optic for MRI yellow Laser Surgery Fiber Radial Emission 400?m Vein Fiber Optic for PLA Long green Laser Surgery Fiber - DiLAS® Laser PLDD Probe Laser Surgery Fiber 600?m 2.6m General Surgery Fiber 400um Corona 360 Radial Fiber 600?m Laser Surgery Fiber 600?m Fiber Optic for PLA Long red Fiber Optic for MRI red Fiber Optic for MRI green Dental Surgery Fiber 320?m Radial Emission Fiber 400?m Laser Surgery Fiber - DiLAS® Laser Slenderflex Venous Probe Laser Surgery Fiber - DiLAS® Laser Fistula Probe WAL Irrigation and Aspiration cannula (Model #: 502001) WAL Irrigation and Aspiration cannula (Model #: 500088) WAL Irrigation and Aspiration cannula (Model #: 500091) Biofill applicator, for Biofill cannulas (for body-jet evo and body-jet eco only) (Model #: 580001) WAL Irrigation and aspiration cannula, 4 long suction holes, 3.8mm D, 30cm L, RAPID, single-use (Model #: 1501125) WAL Irrigation and Aspiration cannula (Model #: 503002) Biofill cannula, 4 long suction holes, 3.8mm D, 15cm L, single-use (Model #: 1580125) body-jet eco, 230V / 120 V/ 100 V (Model #: 500000-8) STS Irrigation/Aspiration cannula, 4.8mm D, 30cm L, 4 suction holes (Model #: 503136) WAL Irrigation and aspiration cannula, 3.8mm D, 30cm L, multi-hole, RAPID, single-use (Model #: 1503004) WAL Irrigation/aspiration cannula, stainless steel, D 4.8mm, L 30cm, multi-hole, RAPID (Model # 503005) harvest Aspiration cannula (Model #: 602012) WAL Infiltration cannula (Model #: 500042) harvest-jet Applicator (for harvest-jet and harvest cannulas only) (Model #: 601001) WAL Irrigation and Aspiration cannula (Model #: 502002) WAL Irrigation and aspiration cannula, 3 long suction holes, 3.8mm D, 30cm L, subcutaneous, single-use (Model #: 1502004 WAL Irrigation and Aspiration cannula (Model #: 500093) WAL Irrigation and Aspiration cannula (Model #: 502003) harvest Infiltration cannula (Model #: 602011) WAL Infiltration cannula, 4.8mm D, 30cm L, single use (Model # 1500121) WAL Irrigation and Aspiration cannula (Model #: 500136) body-jet with weighing system, 120 V (Model #: 500000-1) WAL Infiltration cannula (Model #: 500070) WAL Infiltration cannula (Model #: 500121) Biofill cannula (Model #: 580086) body-jet evo, 120 V (Model #: 500000-17) WAL Irrigation and aspiration cannula, 4 long suction holes, 3.8mm D, 30cm L, single-use (Model #: 1500125) harvest-jet without weighing system, 120 V (Model #: 500000-5) Biofill cannula, 3.8mm D, 15cm L, 4 suction holes, RAPID (Model #: 581125) WAL Irrigation and Aspiration cannula (Model #: 500119) WAL Irrigation and Aspiration cannula, stainless steel, 3.8mm D, 15cm L, 2x2 long suction holes, RAPID (Model #: 501151) WAL applicator, short (Model #: 500001K) WAL Irrigation and Aspiration cannula, spoon-shaped tip (Model #: 500063) WAL Irrigation and aspiration cannula, 4.8mm D, 30cm L, multi-hole, RAPID, single-use (Model #: 1503005) WAL Irrigation and Aspiration cannula (Model #: 500092) STS Irrigation/Aspiration cannula, 4.2mm D, 30cm L, 4 suction holes (Model #: 503148) WAL applicator (Model #: 500001) STS Infiltration cannula, 2.5mm D, 25cm L (Model #: 503070) WAL Irrigation and Aspiration cannula (Model #: 501092) WAL Irrigation and Aspiration cannula (Model #: 500089) WAL Irrigation and Aspiration cannula (Model #: 500148) Biofill cannula, 3.8mm D, 15cm L, 4 suction holes (Model #: 580125) WAL Infiltration cannula (Model #: 500028) Spacer for 15 cm cannulas, non sterile, reusable (Model #: 500054) WAL Irrigation and aspiration cannula, sterile, single use, 2.5 mm D, 15cm L, 180 spray jet straight (Model #: 500114S) WAL Irrigation and Aspiration cannula (Model #: 500125) WAL Irrigation and Aspiration cannula (Model #: 501089) WAL Irrigation/aspiration cannula, stainless steel, D 3.8mm, L 30cm, multi-hole, RAPID (Model # 503004) Biofill cannula, 2 long suction holes, 3.5mm D, 15cm L, single-use (Model #: 1580086) WAL Irrigation and Aspiration cannula (Model #: 502004) WAL Infiltration cannula, 2.5mm D, 30cm L, single-use (Model #: 1500127) STS Irrigation/Aspiration cannula, 3.8mm D, 30cm L, 4 suction holes, RAPID (Model #: 503002) WAL Irrigation and Aspiration cannula (Model #: 503001) Biofill Infiltration cannula (Model #: 580107) Hydrophobic filter set (Model #: 101947) WAL Irrigation and Aspiration cannula (Model #: 501125) WAL Applicator, 370 cm (for body-jet evo only) (Model #: 570001) STS Irrigation/Aspiration cannula, 3.8mm D, 30cm L, 3 suction holes, SUBCUTANEOUS (Model #: 503204) WAL Irrigation and aspiration cannula, 4 long suction holes, 4.2mm D, 30cm L, single-use (Model #: 1500148) WAL Irrigation and Aspiration cannula (Model #: 500149) WAL Irrigation and Aspiration cannula (Model #: 501119) Biofill cannula, 4 long suction holes, 3.5mm D, 15cm L, single-use (Model #: 1580089) WAL Infiltration cannula (Model #: 500107) Biofill Infiltration cannula, 2.5mm D, 15cm L, single-use (Model #: 1580107) Hydrophobic filter set (for body-jet evo) (Model #: 103532) WAL Irrigation and Aspiration cannula (Model #: 500086) Biofill cannula (Model #: 580089) WAL Infiltration cannula (Model #: 503003) Biofill cannula, 4 long suction holes, 3.8mm D, 15cm L, RAPID, single-use (Model #: 1581125) WAL Irrigation and Aspiration cannula (Model #: 500117) STS Infiltration cannula, 3.5mm D, 30cm L (Model #: 503003) WAL Irrigation and aspiration cannula, 4 long suction holes, 4.8mm D, 30cm L, single-use (Model #: 1500136) STS Irrigation/Aspiration cannula, 3.8mm D, 30cm L, 4 suction holes (Model #: 503001) STS Irrigation/Aspiration cannula, 3.5mm D, 30cm L, 4 suction holes (Model #: 503089) SPROTTE® STANDARD 2.G CATHETER, CONDUCTION, ANESTHETIC Tubing Set Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories Sterile Cover Kit NEURO-PATCH RayPilot Power box RayPilot Transmitter Cable RayPilot Quality Control kit RayPilot ViewCath RayPilot Matching Network RayPilot Table displacement meter RayPilot System Cable RayPilot Software RayPilot HypoCath RayPilot Extension plate RayPilot Transmitter tester RayPilot Receiver Hydrofilm Atrauman Silicone 20x30 P5 Atrauman Silicone 5x7 P5 Atrauman Silicone 5x7 P10 Atrauman Silicone 7,5x10 P5 Atrauman Silicone 10x20 P10 Atrauman Silicone 7,5x10 P10 Atrauman Silicone 10x20 P5 Syringe, piston Lyograft ATMOS S 201 Thorax Sono MSK PENTAX Medical Single Use Video Bronchoscope EB15-S01 PENTAX Medical Single Use Video Bronchoscope EB11-S01

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2023-12-22
FOG	Hood, Oxygen, Infant	Anesthesiology	Class 1	868.5700	2022-09-15
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2014-02-21
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2023-12-22
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-05-20
QKL	Lipoaspirate Washing System For Aesthetic Body Contouring	General, Plastic Surgery	Class 2	878.5040	2024-12-10
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2023-12-22
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2022-09-15
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2025-07-21
JAD	System, Therapeutic, X-Ray	Radiology	Class 2	892.5900	2026-01-15
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2022-07-01
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-05-08
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2025-07-21
GFD	Dermatome	General, Plastic Surgery	Class 1	878.4820	2023-03-28
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2023-12-22
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2023-12-22
OTL	Femtosecond Laser System For Refractive Correction	Unknown	Class 3	N/A	2021-09-09
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2025-07-21
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-12-22
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2020-07-22
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2020-07-28
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2024-12-10
ODE	Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)	Gastroenterology, Urology	Class 2	876.1500	2024-11-07
QWN	Stent Graft, Infrapopliteal, Venous Arterialization	Unknown	Class 3	N/A	2023-12-11
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-05-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-05-20
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2025-01-03
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2015-06-24
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-05-20
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2015-06-24
MGZ	Valvulotome	Cardiovascular	Class 2	870.4885	2023-03-28
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2013-02-06
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2022-07-01
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2024-08-19
EYA	Stylet, Ureteral	Gastroenterology, Urology	Class 1	876.5130	2015-12-07
PTL	Wire, Guide, Catheter, Exempt	Cardiovascular	Class 2	870.1330	2022-09-15
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2023-12-22
PDU	Catheter For Crossing Total Occlusions	Cardiovascular	Class 2	870.1250	2023-03-28
JXI	Cuff, Nerve	Neurology	Class 2	882.5275	2019-12-11
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-06-17
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2024-12-10
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2025-07-21
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2015-06-15
BWC	Needle, Emergency Airway	Anesthesiology	Class 2	868.5090	2022-06-17
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2022-06-17
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2023-12-22
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2023-05-08
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2013-02-06
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-03-28
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2015-06-24
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2024-12-10
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2015-06-24
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2026-02-20
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2022-07-01
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2025-03-25
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2018-02-16
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-12-22
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2022-07-01
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2021-08-24
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2025-07-21
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2024-05-03

Official Correspondent

Regina Koelzsch

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

HA2 Medizintechnik GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0001-2018	Carl Zeiss Meditec AG Rudolf-Eber-Str. 11 Oberkochen Germany	2	Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy treatments
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009039068. Last updated year: 2026. Please use registration number 3009039068 when referencing this establishment in official correspondence.