Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611273

FEI Number

3002806486

Entity Name

A. BETZLER GmbH & Co. KG

City/State/Country

TUTTLINGEN-NENDINGEN Baden-Wurttemberg, DE

Establishment Address

INDUSTRIESTRASSE 18, TUTTLINGEN-NENDINGEN Baden-Wurttemberg D-78532, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

A. BETZLER GmbH & Co. KG (Owner Number: 8010529)

Owner / Operator Contact Address

INDUSTRIESTRASSE 18, --, TUTTLINGEN-NENDINGEN, DE-BW D-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
KOH	Instrument, Manual, General Obstetric-Gynecologic	Obstetrics/Gynecology	Class 1	884.4520	2017-09-14
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	1981-04-28
JZB	Scissors, Ear	Ear, Nose, Throat	Class 1	874.4420	2013-12-04
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	1981-04-28
EKD	Instrument, Cutting, Operative	Dental	Class 1	872.4565	1981-04-28
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-12-21

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

A. BETZLER GmbH & Co. KG

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
K914226	E.I. Dupont DE Nemours & Co., Inc.	ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK	1991-11-19

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611273. Last updated year: 2026. Please use registration number 9611273 when referencing this establishment in official correspondence.