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Serum Bone Marker Level 1 Control (serum Bone Marker Control 1)
EUDAMEDClass B (EU MDR)
Ref SBM10574
Identity
- Trade Name
- SERUM BONE MARKER LEVEL 1 CONTROL (SERUM BONE MARKER CONTROL 1) EUDAMED
- Device Name
- SERUM BONE MARKER CONTROL EUDAMED
- Model / Reference
- SBM10574 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055273219098 EUDAMED
- Basic UDI-DI
- 50552732BSUBOMK154TC EUDAMED
- EMDN Code
- W0102152099 CONTROLS- IMMUNOCHEMISTRY - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
Serum Bone Marker Level 1 Control (serum Bone Marker Control 1) 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 | 50552732BSUBOMK154TC | Class B | Active |
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Manufacturer
- Manufacturer
- Randox Laboratories Limited
- EUDAMED SRN
- XI-MF-000028410
Sources (1)
- EUDAMED acc247df-f908-4dc4-b35d-8105f6434a48 61 fields · synced Jul 18, 2026