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Advance Dx Blood Collection Card
EUDAMEDClass A (EU MDR)
Ref CMT01-MEGARef CMT01-DBLRef WTS500Ref WTSSNG500Ref LLS200
Identity
- Trade Name
- Advance Dx Blood Collection Card EUDAMED
- Device Name
- Advance Dx Blood Collection Card: Triple-Single strip cards EUDAMEDAdvance Dx Blood Collection Card: Double strip cards EUDAMEDAdvance Dx Blood Collection Card (5-100 Packs) 500 Single strip cards and 500 foil-Lifeline EUDAMEDAdvance Dx Blood Collection Card: (5-100 Packs) 500 single strip cards and 500 foil EUDAMEDAdvance Dx Blood Collection Card (5-100 Packs) 500 Double strip cards and 500 foil-Lifeline EUDAMED
- Model / Reference
- CMT01-MEGA EUDAMEDCMT01-DBL EUDAMEDWTS500 EUDAMEDWTSSNG500 EUDAMEDLLS200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860013988081 EUDAMED00860013988074 EUDAMED00860013988029 EUDAMED00860013988050 EUDAMED00860013988036 EUDAMED
- Basic UDI-DI
- 08600139880BUDI0011FY EUDAMED08600139880BUDI0010FW EUDAMED08600139880BUDI0005G5 EUDAMED08600139880BUDI0008GB EUDAMED08600139880BUDI0006G7 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
EUDAMEDEUDAMED
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 | 08600139880BUDI0011FY | 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 (5)
- EUDAMED f5b04d0f-5b71-494b-993c-488c2ac5197b 61 fields · synced Aug 3, 2026
- EUDAMED a4ebd7d2-af9f-4f02-89a0-265c0e2218c7 61 fields · synced May 18, 2026
- EUDAMED 75c1e2f8-223e-4bec-89bc-ff79c2ade67e 61 fields · synced May 18, 2026
- EUDAMED 54b6a02f-bedd-4141-9e2a-4db4ecc9cd6d 61 fields · synced May 18, 2026
- EUDAMED d83cace6-2b11-4bff-b96e-2e315927c1eb 61 fields · synced May 18, 2026