Identity
- Trade Name
- B20 EUDAMED
- Device Name
- B20 (Heated) EUDAMED
- Model / Reference
- BB20-H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060969430046 EUDAMED
- Basic UDI-DI
- 506096943BB20H2S EUDAMED
- EMDN Code
- W0201020180 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Romania 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
B20 by Bee Robotics — 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 | 506096943BB20H2S | Class A | Active |
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Manufacturer
- Manufacturer
- Bee Robotics
- EUDAMED SRN
- GB-MF-000023998
- Authorised Representative
- CS Life Sciences Europe Ltd IE-AR-000004113
Sources (1)
- EUDAMED e5223200-b6dc-4e08-b961-b12a8329fa93 61 fields · synced Jun 19, 2026