Identity
- Trade Name
- DAU Negative Calibrator EUDAMED
- Device Name
- DAU Negative Calibrator EUDAMED
- Model / Reference
- ODC6314 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15099590070137 EUDAMED
- Basic UDI-DI
- 150995902ODC6314AK EUDAMED
- EMDN Code
- W0102152201 TDM/DRUG STANDARDS AND CALIBRATORS EUDAMED
Classification
- Device Class
- Class B 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
DAU Negative Calibrator 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 | 150995902ODC6314AK | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beckman Coulter Ireland Inc.
- EUDAMED SRN
- IE-MF-000000887
Sources (1)
- EUDAMED 79dff7d0-e58f-4353-ad8d-d91163db5206 61 fields · synced Aug 3, 2026