Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008808042

FEI Number

3008808042

Entity Name

H.+H. Maslanka Chirurgische Instrumente GmbH

City/State/Country

Tuttlingen Baden-Wurttemberg, DE

Establishment Address

Stockacherstr. 172, Tuttlingen Baden-Wurttemberg 78532, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

H.+H. Maslanka Chirurgische Instrumente GmbH (Owner Number: 10034789)

Owner / Operator Contact Address

Stockacherstr. 172, 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
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2011-01-03
GEE	Brush, Biopsy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2011-01-03
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2026-01-20
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2011-01-03
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-06-23
FGO	Dislodger, Stone, Flexible	Gastroenterology, Urology	Class 2	876.4680	2011-01-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-12-18

Official Correspondent

Marcelina Dudkowski

US Agent Details

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

Related Public Records

Same Entity

H.+H. Maslanka Chirurgische Instrumente 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
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2013	US Endoscopy Group Inc	2	Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

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2124215	Boston Scientific Corporation	Saint Paul, MN, US
3033434906	JIANGSU POWER-ENDO MEDICAL TECHNOLOGY CO., LTD.	Changzhou Jiangsu, CN
3008843439	HANGZHOU KANGJI MEDICAL INSTRUMENT CO., LTD.	HANGZHOU Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008808042. Last updated year: 2026. Please use registration number 3008808042 when referencing this establishment in official correspondence.