FDA Registration
Active
🇩🇪 Germany
MEDICOPLAST INTERNATIONAL GMBH
Reg #: 9617429
·
FEI: 3002807584
·
Expires 2026
Products
11
Proprietary Names
19
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- MEDICOPLAST INTERNATIONAL GMBH
- Registration Number
- 9617429
- FEI Number
- 3002807584
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- HEUSWEILER STRASSE 100
- City
- ILLINGEN Saarland
- Country
- DE
Owner / Operator
- Firm Name
- Medicoplast International GmbH
- Operator Number
- 9035331
- Address
- Heusweilerstrasse 100
- City
- Illingen
- State
- Saarland
- Postal Code
- D-66557
- Country
- DE
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2018-08-24 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2018-08-24 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2023-05-30 |
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2019-02-26 |
| Marker, Radiographic, Implantable | NEU | Class 2 | General, Plastic Surgery | No | 2019-02-26 |
| Needle, Tumor Localization | MIJ | Class 1 | General, Plastic Surgery | No | 2019-02-26 |
| Transcatheter Septal Occluder (Atrial) | OZG | Class 3 | Unknown | No | 2024-07-15 |
| Trap, Sterile Specimen | BYZ | Class 2 | General Hospital | No | 2021-12-20 |
| Device, Percutaneous, Biopsy | MJG | Class 1 | General, Plastic Surgery | No | 2019-02-26 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2008-05-22 |
| Powered Microneedle Device | QAI | Class 2 | General, Plastic Surgery | No | 2023-06-01 |
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
Safety needle cartridge 6-MNP 1.5 Exceed US
Tumark Vision
ERBE ERBEJET®2 System
ERBE APC Integrated Filter Probes and Adapter
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)