Identity
- Trade Name
- Myoglobin EUDAMED
- Device Name
- Myoglobin EUDAMED
- Model / Reference
- OSR6168 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15099590010652 EUDAMED
- Basic UDI-DI
- 150995902OSR6168N8 EUDAMED
- EMDN Code
- W0102019099 SPECIFIC PROTEINS - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- 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
Myoglobin by Beckman Coulter Ireland Inc. — 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 | 150995902OSR6168N8 | Class B | Active |
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Manufacturer
- Manufacturer
- Beckman Coulter Ireland Inc.
- EUDAMED SRN
- IE-MF-000000887
Sources (1)
- EUDAMED 2b4c32ac-b922-42b3-a63e-7b4a0e926c81 61 fields · synced Jul 10, 2026