AMNOTEC INTERNATIONAL MEDICAL GMBH

FDA Device Registration & Listing · Neuhausen ob Eck Baden-Wurttemberg, DE · Registration 3014615697

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014615697
FEI Number
3014615697
Entity Name
AMNOTEC INTERNATIONAL MEDICAL GMBH
City/State/Country
Neuhausen ob Eck Baden-Wurttemberg, DE
Establishment Address
Take-Off-Gewerbepark 12, Neuhausen ob Eck Baden-Wurttemberg 78579, DE
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Amnotec International Medical GmbH (Owner Number: 10057846)
Owner / Operator Contact Address
Take-Off-Gewerbepark 12, Neuhausen ob Eck, DE-BW 78579, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HRX Arthroscope Orthopedic Class 2 888.1100 2021-07-11
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2018-06-28
BZN Cart, Emergency, Cardiopulmonary (Excluding Equipment) Anesthesiology Class 1 868.6175 2023-06-15
EIB Syringe, Irrigating (Dental) Dental Class 1 872.4565 2022-06-21
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2018-06-28
KBN Gag, Mouth Ear, Nose, Throat Class 1 874.4420 2018-07-08
EPY Speculum, Ent General, Plastic Surgery Class 1 878.1800 2018-06-27
EMG Forceps, Tooth Extractor, Surgical Dental Class 1 872.4565 2018-06-26
KCI Trocar, Tracheal Ear, Nose, Throat Class 1 874.4420 2018-07-08
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2021-07-11
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2021-07-11
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2018-06-28
ERA Otoscope Ear, Nose, Throat Class 1 874.4770 2018-07-09
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2019-08-28
FNY Basin, Emesis General Hospital Class 1 880.6730 2018-06-27
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-09-02
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2021-07-12
LQC Lithotriptor, Biliary Mechanical Gastroenterology, Urology Class 2 876.4500 2021-07-27
KBE Snare, Nasal Ear, Nose, Throat Class 1 874.4420 2018-07-08
JZB Scissors, Ear Ear, Nose, Throat Class 1 874.4420 2018-07-08
HDJ Scissors, Umbilical Obstetrics/Gynecology Class 1 884.4520 2018-06-02
GAI Stripper, Vein, Reusable General, Plastic Surgery Class 1 878.4800 2018-06-28
EMH Forceps, Rongeur, Surgical Dental Class 1 872.4565 2018-06-26
JYR Nipper, Malleus Ear, Nose, Throat Class 1 874.4420 2018-07-08
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2018-08-21
GDM Needle, Aspiration And Injection, Reusable General, Plastic Surgery Class 1 878.4800 2018-06-28
KBG Trocar, Sinus Ear, Nose, Throat Class 1 874.4420 2018-07-08
KBH Adenotome Ear, Nose, Throat Class 1 874.4420 2018-07-08
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2018-06-27
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2018-07-08
JXX Forceps, Wire Closure, Ent, Sterile Ear, Nose, Throat Class 1 874.3540 2018-07-08
GDL Needle, Suturing, Reusable General, Plastic Surgery Class 1 878.4800 2018-06-28
HRR Scissors, Orthopedic, Surgical Orthopedic Class 1 888.4540 2018-07-08
KAP Curette, Nasal Ear, Nose, Throat Class 1 874.4420 2018-07-08
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2018-07-09
EZO Urethrotome Gastroenterology, Urology Class 2 876.4770 2021-07-11
KAS Knife, Nasal Ear, Nose, Throat Class 1 874.4420 2018-07-08
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2018-08-21
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2020-06-25
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2020-06-25
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2020-06-25
HXY Brace, Drill Orthopedic Class 1 888.4540 2018-07-08
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-03-10
KBZ Snare, Tonsil Ear, Nose, Throat Class 1 874.4420 2018-07-08
KBJ Curette, Adenoid Ear, Nose, Throat Class 1 874.4420 2018-07-08
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 2018-07-08
FNS Ring Cutter General Hospital Class 1 880.6200 2018-06-27
KAE Forceps, Ent Ear, Nose, Throat Class 1 874.4420 2018-07-08
HTF Curette General, Plastic Surgery Class 1 878.4800 2018-07-08
HCY Curette, Uterine Obstetrics/Gynecology Class 1 884.4530 2018-07-07
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2018-07-08
FFQ Speculum, Rectal Gastroenterology, Urology Class 1 876.4730 2018-06-27
HTD Forceps General, Plastic Surgery Class 1 878.4800 2018-07-08
GDN Knife, Amputation General, Plastic Surgery Class 1 878.4800 2018-06-28
KAD Elevator, Ent Ear, Nose, Throat Class 1 874.4420 2018-07-08
JZE Spoon, Ear Ear, Nose, Throat Class 1 874.4420 2018-07-08
EMF Knife, Surgical General, Plastic Surgery Class 1 878.4800 2018-06-26
JZD Snare, Ear Ear, Nose, Throat Class 1 874.4420 2018-07-08
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 2018-07-08
FFL Dislodger, Stone, Basket, Ureteral, Metal Gastroenterology, Urology Class 2 876.4680 2021-07-27
EEF Clamp, Rubber Dam Dental Class 1 872.6300 2021-09-10
JYC Cannula, Ear General, Plastic Surgery Class 1 878.4800 2018-07-08
EGN Scissors, Surgical Tissue, Dental Dental Class 1 872.4565 2018-06-26
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2018-07-08
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 2018-07-08
GWY Pinwheel Neurology Class 1 882.1750 2018-06-28
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2021-07-11
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2018-06-28
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2018-07-09
LWK Razor, Surgical General, Plastic Surgery Class 1 878.4800 2018-07-08
HNL Probe, Lachrymal Ophthalmic Class 1 886.4350 2018-07-08
KDG Chisel (Osteotome) General, Plastic Surgery Class 1 878.4820 2018-07-02
JYG Curette, Ear Ear, Nose, Throat Class 1 874.4420 2018-07-08
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2018-07-09
HBT Applier, Hemostatic Clip General, Plastic Surgery Class 1 878.4800 2018-06-28
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2018-07-08
HFB Forceps, Biopsy, Gynecological Obstetrics/Gynecology Class 1 884.4530 2018-07-07
GXJ Punch, Skull Neurology Class 1 882.4750 2018-06-28
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 2018-07-07
FHA Clamp, Penile Gastroenterology, Urology Class 1 876.5160 2018-06-27
OAR Injector, Vertebroplasty (Does Not Contain Cement) Orthopedic Class 1 888.4200 2022-12-14
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2018-07-08
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2018-06-28
FFD Evacuator, Bladder, Manually Operated Gastroenterology, Urology Class 1 876.4370 2021-07-11
HRX Arthroscope Orthopedic Class 2 888.1100 2018-07-09
KBM Dissector, Tonsil Ear, Nose, Throat Class 1 874.4420 2018-07-08
KBR Needle, Tonsil Suturing Ear, Nose, Throat Class 1 874.4420 2018-07-08
KCG Dilator, Tracheal Ear, Nose, Throat Class 1 874.4420 2018-07-08
EJE Frame, Rubber Dam Dental Class 1 872.6300 2021-09-10
JYF Clamp, Ossicle Holding Ear, Nose, Throat Class 1 874.4420 2018-07-08
LGG Instrument, Cast Application/Removal, Manual Orthopedic Class 1 888.5980 2018-07-08

Official Correspondent

Milorad Perazic

US Agent Details

Beate Weiss-Krull Business: Beate Weiss-Krull, Attorney at Law Email: bea@weisskrull-law.com Phone: (503) 2340355

Related Public Records

Same Entity

Amnotec International Medical 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
K081051 Spine View, Inc. SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE 2008-08-07
K820777 The Anspach Effort, Inc. MINI-MICRO ARTHROSCOPIC SCAPEL 1982-05-12
K851170 The Huxley Instrument Corp. DISSECTING TWEEZER #283-72PCS. SS 410 1985-04-25
K821248 Conphar, Inc. ROCHESTER PEAN FORCEPS 1982-05-28
K834189 Imm Enterprises , Ltd. JAKOBI SURG. INSTRUMENTS #7 44/47 1984-03-06

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-05 Linvatec Corp. 2
Ultra Power Burs, Sterile, Single-Use.
Z-0012-2008 Becton Dickinson & Company 1
Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008 Becton Dickinson & Company 1
Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014615697. Last updated year: 2026. Please use registration number 3014615697 when referencing this establishment in official correspondence.
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