Identity
- Device Name
- EDTA Capillary Tubes EUDAMED
- Model / Reference
- 7D2227 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04571226475430 EUDAMED
- Basic UDI-DI
- 457122647DCN00032E EUDAMED
- EMDN Code
- W0501010203 BLOOD COLLECTION, CAPILLARY TUBES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
EDTA Capillary Tubes by Abbott Diagnostics Medical Co., Ltd. — Class A — 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 | 457122647DCN00032E | Class A | Active |
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Manufacturer
- Manufacturer
- Abbott Diagnostics Medical Co., Ltd.
- EUDAMED SRN
- JP-MF-000009543
- Authorised Representative
- Abbott Rapid Dx International Limited IE-AR-000000091
Sources (1)
- EUDAMED 1b551d55-0fcd-4077-815b-b401b4718f27 61 fields · synced Jul 9, 2026