OERTEL MEDICAL GMBH

FDA Device Registration & Listing · TUTTLINGEN Baden-Wurttemberg, DE · Registration 9612075

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
9612075
FEI Number
3002809480
Entity Name
OERTEL MEDICAL GMBH
City/State/Country
TUTTLINGEN Baden-Wurttemberg, DE
Establishment Address
OBERE VORSTADT 19-20, TUTTLINGEN Baden-Wurttemberg D-78532, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
OERTEL MEDICAL GMBH (Owner Number: 8010226)
Owner / Operator Contact Address
OBERE VORSTADT 19-20, --, TUTTLINGEN, DE-BW D-78532, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Curette, Nasal RASP Retractor

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GDH Gouge, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1994-03-07
HRT Stripper, Surgical Orthopedic Class 1 888.4540 1998-06-08
JYO Knife, Ear Ear, Nose, Throat Class 1 874.4420 1986-06-24
KAS Knife, Nasal Ear, Nose, Throat Class 1 874.4420 1984-09-07
KTG Knife, Ent Ear, Nose, Throat Class 1 874.4420 2013-01-16
HNI Retractor, Ophthalmic Ophthalmic Class 1 886.4350 2000-04-13
EMM Chisel, Osteotome, Surgical Dental Class 1 872.4565 2013-01-16
HND Spatula, Ophthalmic Ophthalmic Class 1 886.4350 1992-10-17
HOE Caliper, Ophthalmic Ophthalmic Class 1 886.4350 1996-11-05
HXB Probe Orthopedic Class 1 888.4540 2003-08-07
HDE Hook, Fibroid, Gynecological Obstetrics/Gynecology Class 1 884.4520 2010-03-24
HTR Rasp General, Plastic Surgery Class 1 878.4800 1994-04-25
EMI File, Bone, Surgical Dental Class 1 872.4565 2013-01-16
KAN Chisel, Nasal General, Plastic Surgery Class 1 878.4800 1984-09-07
KAP Curette, Nasal Ear, Nose, Throat Class 1 874.4420 1983-09-27
GAD Retractor General, Plastic Surgery Class 1 878.4800 1992-10-17
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 1986-06-24
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2013-01-16
EJB Handle, Instrument, Dental Dental Class 1 872.4565 1994-04-25
JZY Knife, Laryngeal Ear, Nose, Throat Class 1 874.4420 1994-01-05
HTF Curette General, Plastic Surgery Class 1 878.4800 1994-04-25
KBQ Knife, Tonsil Ear, Nose, Throat Class 1 874.4420 1984-09-07
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 1986-06-24
GCC Dilator, Catheter General, Plastic Surgery Class 1 878.4200 1997-04-02
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1986-06-24
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 1986-06-24
HMR Marker, Ocular Ophthalmic Class 1 886.4570 1992-10-17
JYP Knife, Myringotomy Ear, Nose, Throat Class 1 874.4420 1983-09-27
HNB Spoon, Ophthalmic Ophthalmic Class 1 886.4350 2013-01-16
HWM Osteotome General, Plastic Surgery Class 1 878.4800 1994-06-08
HNC Specula, Ophthalmic Ophthalmic Class 1 886.4350 1999-06-07
HLN Gauge, Lens, Ophthalmic Ophthalmic Class 1 886.1420 1992-10-17
HXG Tamp Orthopedic Class 1 888.4540 1997-05-23
KAD Elevator, Ent Ear, Nose, Throat Class 1 874.4420 1978-04-25
GAC Rasp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1986-06-24
KBM Dissector, Tonsil Ear, Nose, Throat Class 1 874.4420 2013-01-16
HNX Depressor, Orbital Ophthalmic Class 1 886.4350 2000-03-22
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2013-03-04
HTS Knife, Orthopedic Orthopedic Class 1 888.4540 1983-09-27
EIG Retractor, All Types Dental Class 1 872.4565 2013-01-16
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2010-06-22
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2013-01-16
HWA Impactor Orthopedic Class 1 888.4540 2000-08-02
KBA Rasp, Nasal Ear, Nose, Throat Class 1 874.4420 1984-09-07

Official Correspondent

No official correspondent registered.

US Agent Details

Angelika Scherp Business: BUSINESS SUPPORT INTERNATIONAL Email: info@bsi-fda.com Phone: (212) 3318358

Related Public Records

Same Entity

OERTEL 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
K922626 Andronic Devices, Ltd. ADEPT INSTRUMENT POSITIONING ACCESSORY 1992-10-19
K820290 The Anspach Effort, Inc. SELF RETAINING RETRACTOR FOR HAND SURG 1982-03-05
K760422 Cutter Laboratories, Inc. SURGICAL RETRACTOR 1976-08-23
K874057 Myocure, Inc. OPHTHALMIC TIP & BLADE SCALPELS 1987-12-23
K854401 Microsurgical Technology, Inc. THE NEW MOBILE TIP MCINTYRE CANNULA 1985-12-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-2014 Aesculap, Inc. 1
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0026-04 Surgical Specialties Corp 1
Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024 Alcon Research LLC Aspex Facility 1
20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024 Alcon Research LLC Aspex Facility 1
ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1924-2024 Alcon Research LLC Aspex Facility 1
ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

Similar Registrations

Registration Number Establishment Name Location
3003644849 DR. FRIGZ INTERNATIONAL (PVT) LTD. SIALKOT, Punjab, PK
9612501 Covidien - Santo Domingo, DO
3011164188 NR SURGICAL COMPANY Sialkot Punjab, PK
3016069968 SURTEX INSTRUMENTS LTD London Surrey, GB
3011625373 METRO MEDICAL Sialkot Punjab, PK
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612075. Last updated year: 2026. Please use registration number 9612075 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.