Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011398162

FEI Number

3011398162

Entity Name

ENDO-PASSION GMBH

City/State/Country

Wurmlingen Baden-Wurttemberg, DE

Establishment Address

Faulenbachstr. 15, Wurmlingen Baden-Wurttemberg 78573, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ENDO-PASSION GmbH (Owner Number: 10041398)

Owner / Operator Contact Address

Faulenbachstr. 15, Wurmlingen, DE-BW 78573, 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
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2021-02-18
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-07-19
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2021-03-04

Official Correspondent

No official correspondent registered.

US Agent Details

Angelika Scherp Business: BSI Business Support International Email: info@bsi-fda.com Phone: (212) 3318358

Related Public Records

Same Entity

ENDO-PASSION 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
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28

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3035678069	MATTES INSTRUMENTE GMBH	Tuttlingen-Nendingen Baden-Wurttemberg, DE
1421879	PHOENIX INSTRUMENTS, INC.	Lisle, IL, US
1123010	TRINITY STERILE, INC.	SALISBURY, MD, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011398162. Last updated year: 2026. Please use registration number 3011398162 when referencing this establishment in official correspondence.