Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614945

FEI Number

3004207793

Entity Name

ROMINGER MEDIZINTECHNIK GMBH

City/State/Country

SEITINGEN-OBERFLACHT Baden-Wurttemberg, DE

Establishment Address

HOHNERSTRASSE 22, SEITINGEN-OBERFLACHT Baden-Wurttemberg 78606, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ROMINGER MEDIZINTECHNIK GMBH (Owner Number: 9030633)

Owner / Operator Contact Address

HOHNERSTRASSE 22, --, SEITINGEN-OBERFLACHT, DE-BW 78606, DE

Initial Importer Flag

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
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2001-06-20
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2012-04-24
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2013-01-21
HBG	Drills, Burrs, Trephines & Accessories (Manual)	Neurology	Class 2	882.4300	2012-06-27
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-01-21
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-11-14
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2025-04-01
HTX	Rongeur	Orthopedic	Class 1	888.4540	2011-08-03
HAE	Rongeur, Manual	Neurology	Class 2	882.4840	2012-04-30
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	2001-06-20
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2024-11-14

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

ROMINGER 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
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
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22

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-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

Similar Registrations

Registration Number	Establishment Name	Location
3032747418	HEXAMED PVT LTD	Sialkot Punjab, PK
9710524	ULTIMATE MEDICAL PRODUCTS LTD.	SHARJAH Ash Shariqah, AE
3010829427	SWANTIA MEDICAL PRIVATE LIMITED	Sialkot Punjab, PK
3009718267	DIVERSITY CORPORATION FZE	Sharjah Ash Shariqah, AE
3016170849	MOSAIC SURGICAL	High Wycombe Buckinghamshire, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614945. Last updated year: 2026. Please use registration number 9614945 when referencing this establishment in official correspondence.