Identity
- Trade Name
- Digoxin Calibrator EUDAMED
- Device Name
- Digoxin Calibrator EUDAMED
- Model / Reference
- ODC6404 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15099590070496 EUDAMED
- Basic UDI-DI
- 150995902ODC6404AM EUDAMED
- EMDN Code
- W0102152201 TDM/DRUG STANDARDS AND CALIBRATORS EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
No
EUDAMED
New Device
No
EUDAMED
Digoxin Calibrator by Beckman Coulter Ireland Inc. — Class C — 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 | 150995902ODC6404AM | Class C | Active |
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Manufacturer
- Manufacturer
- Beckman Coulter Ireland Inc.
- EUDAMED SRN
- IE-MF-000000887
Sources (1)
- EUDAMED 334bd7a5-b133-4bac-9d31-8e0382a7cc55 61 fields · synced Oct 6, 2026