Identity
- Trade Name
- WELLCOGEN EDTA SOLUTION EUDAMED
- Device Name
- WELLCOGEN EDTA SOLUTION EUDAMED
- Model / Reference
- R30164501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056080502076 EUDAMED
- Basic UDI-DI
- 50560805WellcoEDTAAY EUDAMED
- EMDN Code
- W0580 IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Wellcogen Edta Solution by Remel Europe Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 50560805WellcoEDTAAY | Class A | Active |
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Manufacturer
- Manufacturer
- Remel Europe Ltd
- EUDAMED SRN
- GB-MF-000016733
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (1)
- EUDAMED f3b5cb3d-3f49-4630-8f50-3caf753413a1 61 fields · synced Jul 23, 2026