Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617429

FEI Number

3002807584

Entity Name

MEDICOPLAST INTERNATIONAL GMBH

City/State/Country

ILLINGEN Saarland, DE

Establishment Address

HEUSWEILER STRASSE 100, ILLINGEN Saarland 66557, DE

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Medicoplast International GmbH (Owner Number: 9035331)

Owner / Operator Contact Address

Heusweilerstrasse 100, Illingen, DE-SL D-66557, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ERBE Water Jet Model ERBEJET® 2 System with HybridAPC Probe Inion Thermo Drape Occlutech VerteStable Mini, VerteStable SIS, VerteStable Cannula Tumark for Eviva, Tumark for Brevera ERBE APC Handle and Applicators ERBE Hybrid KnifeTM Tumark Professional, Tumark Professional X-Shape, Tumark MRI, Tumark Eye, Tumark Vision MRI TULOC, TULOC PREMIUM, MRI TULOC, Q-Wire System, Duo System Stereo Tumark Professional; Tumark Professional Q-shape; Tumark Q Occlutech® Manual Sterile SpecimenHAE - Rongeur Trap MRI Coaxial Puncture Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2018-08-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-08-24
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2023-05-30
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2019-02-26
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2019-02-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-08-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-08-23
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2019-02-26
MIJ	Needle, Tumor Localization	General, Plastic Surgery	Class 1	878.4800	2019-02-26
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2019-02-26
OZG	Transcatheter Septal Occluder (Atrial)	Unknown	Class 3	N/A	2024-07-15
BYZ	Trap, Sterile Specimen	General Hospital	Class 2	880.6740	2021-12-20
MJG	Device, Percutaneous, Biopsy	General, Plastic Surgery	Class 1	878.4800	2019-02-26

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Medicoplast International 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
K213616	Becton, Dickinson and Company	BD Surgiphor Antimicrobial Irrigation System	2022-03-23
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617429. Last updated year: 2026. Please use registration number 9617429 when referencing this establishment in official correspondence.