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Custom Bilirubin Control - Level 3 (CUSTOM BILIRUBIN CONTROL 3)
EUDAMEDClass B (EU MDR)
Ref BR10391
Identity
- Trade Name
- Custom Bilirubin Control - Level 3 (CUSTOM BILIRUBIN CONTROL 3) EUDAMED
- Device Name
- Custom Bilirubin Control - Level 3 (CUSTOM BILIRUBIN CONTROL 3) EUDAMED
- Model / Reference
- BR10391 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055273217926 EUDAMED
- Basic UDI-DI
- 50552732BLBCNL30345F EUDAMED
- EMDN Code
- W0101050203 BILIRUBIN CONTROLS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
Custom Bilirubin Control - Level 3 (CUSTOM BILIRUBIN CONTROL 3) by Randox Laboratories Limited — Class B — IVDR — listed in EUDAMED
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 | 50552732BLBCNL30345F | Class B | Active |
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Manufacturer
- Manufacturer
- Randox Laboratories Limited
- EUDAMED SRN
- XI-MF-000028410
Sources (1)
- EUDAMED 8e03e3c6-acf1-4088-8fb9-004e18eb7266 61 fields · synced Jul 29, 2026