Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004083789

FEI Number

3004083789

Entity Name

AS MEDIZINTECHNIK GMBH

City/State/Country

TUTTLINGEN Baden-Wurttemberg, DE

Establishment Address

SATTLERSTRASSE 15, TUTTLINGEN Baden-Wurttemberg 78532, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

AS MEDIZINTECHNIK GMBH (Owner Number: 9056824)

Owner / Operator Contact Address

15, SATTLERSTRASSE, --, TUTTLINGEN, DE-BW 78532, 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
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2008-03-15
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2020-10-14
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2008-02-12
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2003-06-09
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2021-07-08
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2020-10-14
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2008-02-12
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2020-10-14

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

AS 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
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

Registration Number	Establishment Name	Location
3016544015	ARCULANT, INC.	Santa Clara, CA, US
1055890	PRINCETON MEDICAL GROUP, INC.	Franklin, TN, US
3004371426	Waldemar Link GmbH & Co. KG	Norderstedt Schleswig-Holstein, DE
3010287737	BAECHLER FEINTECH AG	Hoelstein Basel-Landschaft, CH
3003675041	SURGICAL INSTRUMENTS BELGIUM SA	GEMBLOUX Namur, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004083789. Last updated year: 2026. Please use registration number 3004083789 when referencing this establishment in official correspondence.