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LUMEA BxBoard Assembly, X1
EUDAMEDClass A (EU MDR)
Ref EBS-BXBD-ASY-0012
by CellPath Ltd
Identity
- Trade Name
- LUMEA BxBoard Assembly, X1 EUDAMED
- Device Name
- BXBOARD EUDAMED
- Model / Reference
- EBS-BXBD-ASY-0012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056256111231 EUDAMED
- Basic UDI-DI
- 05056256EBS0012E EUDAMED
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
LUMEA BxBoard Assembly, X1 by CellPath 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 | 05056256EBS0012E | Class A | Active |
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Manufacturer
- Manufacturer
- CellPath Ltd
- EUDAMED SRN
- GB-MF-000022744
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 16091598-cfcc-49eb-9d41-0ddcef3bdeb0 61 fields · synced Jul 11, 2026