Identity
- Device Name
- Fixation devices EUDAMED
- Model / Reference
- ME-FD2000S EUDAMEDME-FD2000L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05430001422115 EUDAMED05430001422108 EUDAMED
- Basic UDI-DI
- 5430001422MEFDLH EUDAMED
- EMDN Code
- V80 CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Fixation devices by MedEnvision bv — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5430001422MEFDLH | Class I | Active |
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Manufacturer
- Manufacturer
- MedEnvision bv
- EUDAMED SRN
- BE-MF-000000329
Sources (2)
- EUDAMED 7d511093-616a-4f54-b9b0-a9a80eb913b3 61 fields · synced Jul 21, 2026
- EUDAMED 09f265a9-d57a-4e69-94b9-e08ff41fda0b 61 fields · synced May 18, 2026