Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014268446

FEI Number

3014268446

Entity Name

OPINSTRUMENTS GMBH

City/State/Country

Rosbach vor der Hoehe Hesse, DE

Establishment Address

Industriestrasse 3, Rosbach vor der Hoehe Hesse 61191, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OpInstruments GmbH (Owner Number: 10056684)

Owner / Operator Contact Address

Industriestrasse 3, Rosbach vor der Hoehe, DE-HE 61191, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Suction Tubes Retractors Fixtures Retractors Fixtures, 04-1101-18 Dissector Micro Scissors, Medical Scissors Bile Duct Dilators Binocular Loupes Bone Bitting Rongeurs Hemostatic Forceps Micro Clamps Micro Tissue Forceps, Tissue Forceps Scalpels Medical Headlight Retractors Needle Holders, Micro-Needle Holders

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2021-09-01
PYH	Surgical Retractor Kit	General, Plastic Surgery	Class 1	878.4800	2018-01-04
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2019-11-04
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2018-01-04
FAX	Bougie, Urological	Gastroenterology, Urology	Class 1	876.5520	2019-11-04
FSP	Loupe, Diagnostic/Surgical	General, Plastic Surgery	Class 1	878.4800	2018-01-04
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2018-01-04
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2018-01-04
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2018-01-04
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2018-01-04
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2018-01-04
EBA	Light, Surgical Headlight	Dental	Class 1	872.4630	2024-07-16
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2018-01-04
HYA	Forceps, Wire Holding	General, Plastic Surgery	Class 1	878.4800	2018-01-04

Official Correspondent

Jiang Shi

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

OpInstruments 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

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3008496217	DERMATO PLASTICA BEAUTY CO., LTD.	Kaohsiung City, TW
3001614464	medi-G GMBH	Messkirch Baden-Wurttemberg, DE
3028006458	ClearPoint Neuro Inc.	Carlsbad, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014268446. Last updated year: 2026. Please use registration number 3014268446 when referencing this establishment in official correspondence.