Identity
- Trade Name
- Advance Dx Blood Collection Card EUDAMED
- Device Name
- Advance Dx Blood Collection Card: Single strip cards, no lines EUDAMED
- Model / Reference
- CMT01.1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860013988067 EUDAMED
- Basic UDI-DI
- 08600139880BUDI0009GD EUDAMED
- EMDN Code
- W0501010199 VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Northern 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
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
Advance Dx Blood Collection Card by Advance Dx, Inc. — 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 | 08600139880BUDI0009GD | Class A | Active |
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Manufacturer
- Manufacturer
- Advance Dx, Inc.
- EUDAMED SRN
- US-MF-000044758
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED feaea400-e54a-4536-8687-9e2eca6fbcf6 61 fields · synced Jun 18, 2026