Identity
- Trade Name
- ORTHOTM Elution Kit EUDAMED
- Device Name
- ORTHOTM Elution Kit EUDAMED
- Model / Reference
- 6324445 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060242472602 EUDAMED
- Basic UDI-DI
- 0506024247FD313BAQ EUDAMED
- EMDN Code
- W0103030399 ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
ORTHOTM Elution Kit by Alba Bioscience Limited — Class B — 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 | 0506024247FD313BAQ | Class B | Active |
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Manufacturer
- Manufacturer
- Alba Bioscience Limited
- EUDAMED SRN
- GB-MF-000029300
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED d56ba345-0007-47cc-b835-5f04165d2195 61 fields · synced Jun 18, 2026