Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015972835

FEI Number

3015972835

Entity Name

HEINRICH MEDIZINTECHNIK GMBH

City/State/Country

Stuttgart Baden-Wurttemberg, DE

Establishment Address

Heilbronner Strasse 150, Stuttgart Baden-Wurttemberg 70191, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Heinrich Medizintechnik GmbH (Owner Number: 10061386)

Owner / Operator Contact Address

Heilbronner Strasse 150, Stuttgart, DE-BW 70191, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

KNIFE, EAR INSUFFLATOR, VAGINAL Endoscopic grasping/cutting instrument, non-powered CAMERA, STILL, ENDOSCOPIC KNIFE, LARYNGEAL INSUFFLATOR, VAGINAL SAW, PNEUMATICALLY POWERED Drill, battery powered CURETTE, ETHMOID ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE APPLIER, HEMOSTATIC CLIP RETRACTOR, ENT RETRACTOR, SELF-RETAINING CAMERA, STILL, ENDOSCOPIC Laparoscopic accessories, gynecologic DISSECTOR, TONSIL Instrument, shunt system Trocar CURETTE, EAR PICK, MICROSURGICAL EAR KNIFE, AMPUTATION CURETTE, NASAL Cardiovascular Delivery Catheter System Positioning and Stabilization Device FORCEPS, DISCONNECT CLAMP, UTERINE KNIFE, SURGICAL CAMERA, SURGICAL AND ACCESSORIES CLAMP, NON-ELECTRICAL SAW, POWERED, AND ACCESSORIES Forceps, obstetrical Gastroenterology-urology accessories to a biopsy instrument Retractor, fiberoptic Trocar, gastro-urology KNIFE, ENT FORCEPS, WIRE HOLDING URETHROMETER FORCEPS, BIOPSY, GYNECOLOGICAL CURETTE, ADENOID CURETTE, SURGICAL, GENERAL USE PUNCH, FEMORAL NECK CLAMPS SPATULA, ORTHOPEDIC KNIFE, TONSIL Telescope, hand-held, low-vision CURETTE, SALPINGEAL Light source, endoscope, xenon arc Light, surgical, endoscopic HOLDER, NEEDLE, GASTROENTEROLOGIC Accessories, arthroscopic CURETTE, UTERINE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JYO	Knife, Ear	Ear, Nose, Throat	Class 1	874.4420	2020-05-17
HEC	Insufflator, Vaginal	Obstetrics/Gynecology	Class 1	884.5920	2023-05-01
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	Gastroenterology, Urology	Class 2	876.1500	2021-07-24
FXM	Camera, Still, Endoscopic	General, Plastic Surgery	Class 1	878.4160	2021-07-24
JZY	Knife, Laryngeal	Ear, Nose, Throat	Class 1	874.4420	2020-05-17
HEC	Insufflator, Vaginal	Obstetrics/Gynecology	Class 1	884.5920	2023-05-01
KFK	Saw, Pneumatically Powered	General, Plastic Surgery	Class 1	878.4820	2021-07-24
NWF	Drill, Battery Powered, Subungual Hematoma	General, Plastic Surgery	Class 1	878.4820	2021-07-24
KAO	Curette, Ethmoid	Ear, Nose, Throat	Class 1	874.4420	2020-05-17
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2021-07-24
HBT	Applier, Hemostatic Clip	General, Plastic Surgery	Class 1	878.4800	2020-05-17
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	2020-05-17
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2020-05-17
FXM	Camera, Still, Endoscopic	General, Plastic Surgery	Class 1	878.4160	2021-07-24
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2021-07-24
KBM	Dissector, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2020-05-17
GYK	Instrument, Shunt System Implantation	Neurology	Class 1	882.4545	2021-09-03
DRC	Trocar	Cardiovascular	Class 2	870.1390	2023-05-01
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2020-05-17
JYT	Pick, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2020-05-17
GDN	Knife, Amputation	General, Plastic Surgery	Class 1	878.4800	2020-05-17
KAP	Curette, Nasal	Ear, Nose, Throat	Class 1	874.4420	2020-05-17
QWA	Cardiovascular Delivery Catheter System Positioning And Stabilization Device	Cardiovascular	Class 1	870.3955	2023-05-01
FJR	Forceps, Disconnect	Gastroenterology, Urology	Class 1	876.5540	2021-09-03
HGC	Clamp, Uterine	Obstetrics/Gynecology	Class 1	884.4520	2020-05-17
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-05-17
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2020-05-17
FFN	Clamp, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2020-05-17
HAB	Saw, Powered, And Accessories	General, Plastic Surgery	Class 1	878.4820	2021-07-24
HDA	Forceps, Obstetrical	Obstetrics/Gynecology	Class 2	884.4400	2020-05-17
QFZ	Gastroenterology-Urology Accessories To A Biopsy Instrument	Gastroenterology, Urology	Class 1	876.1080	2021-09-03
FDG	Retractor, Fiberoptic	Gastroenterology, Urology	Class 1	876.4530	2020-05-17
FBQ	Trocar, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5090	2021-09-03
KTG	Knife, Ent	Ear, Nose, Throat	Class 1	874.4420	2020-05-17
HYA	Forceps, Wire Holding	General, Plastic Surgery	Class 1	878.4800	2020-05-17
FBR	Urethrometer	Gastroenterology, Urology	Class 1	876.5520	2021-09-03
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2020-05-17
KBJ	Curette, Adenoid	Ear, Nose, Throat	Class 1	874.4420	2020-05-17
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2020-05-17
HWP	Punch, Femoral Neck	Orthopedic	Class 1	888.4540	2020-05-17
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2020-05-17
HXR	Spatula, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2020-05-17
KBQ	Knife, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2020-05-17
HKB	Telescope, Hand-Held, Low-Vision	Ophthalmic	Class 1	886.5870	2023-05-01
KBK	Curette, Salpingeal	Ear, Nose, Throat	Class 1	874.4420	2020-05-17
GCT	Light Source, Endoscope, Xenon Arc	Gastroenterology, Urology	Class 2	876.1500	2020-05-17
FSW	Light, Surgical, Endoscopic	General, Plastic Surgery	Class 2	878.4580	2021-07-24
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2020-05-17
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2023-05-01
HCY	Curette, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2020-05-17

Official Correspondent

Ginni Heinrich

US Agent Details

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

Related Public Records

Same Entity

Heinrich Medizintechnik GmbH

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-05	N/A	1	Hem-o-lok Endo5 Ligation Applier
Z-0034-2012	X Spine Systems Inc	1	Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.
Z-0040-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0041-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0042-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

Similar Registrations

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3012507533	Integra Canada ULC	Oakville Ontario, CA
3004608878	INTEGRA LIFESCIENCES CORPORATION	CINCINNATI, OH, US
3011050570	Gyrus ACMI, Inc.	Brooklyn Park, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015972835. Last updated year: 2026. Please use registration number 3015972835 when referencing this establishment in official correspondence.