Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015490794

FEI Number

3015490794

Entity Name

DOPPKON GMBH & CO. KG

City/State/Country

Spaichingen Baden-Wurttemberg, DE

Establishment Address

Einsteinstrasse 30, Spaichingen Baden-Wurttemberg 78549, DE

Establishment Type(s)

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

Owner / Operator

DOPPKON GmbH & Co. KG (Owner Number: 10091676)

Owner / Operator Contact Address

Einsteinstrasse 30, Spaichingen, DE-BW 78549, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

A-001-157

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	2024-10-23
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2024-10-23
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-10-23
HAS	Needle, Neurosurgical Suture	Neurology	Class 1	882.4650	2024-10-23
DRC	Trocar	Cardiovascular	Class 2	870.1390	2024-10-23
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2024-10-23
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-10-23
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-10-23
HXB	Probe	Orthopedic	Class 1	888.4540	2024-10-23
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-10-23
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2024-10-23
HXO	Pusher, Socket	Orthopedic	Class 1	888.4540	2024-10-23
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2024-10-23
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2024-10-23
HRT	Stripper, Surgical	Orthopedic	Class 1	888.4540	2024-10-23
HWK	Trephine	Orthopedic	Class 1	888.4540	2024-10-23
HTX	Rongeur	Orthopedic	Class 1	888.4540	2024-10-23

Official Correspondent

MEDAGENT Servicepoint

US Agent Details

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

Related Public Records

Same Entity

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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.

Similar Registrations

Registration Number	Establishment Name	Location
3005374323	SPECTRUM SURGICAL SUPPLIES	SIALKOT Punjab, PK
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
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 3015490794. Last updated year: 2026. Please use registration number 3015490794 when referencing this establishment in official correspondence.