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Sol-M Evacuated Blood Collection Tubes
EUDAMEDClass IVD General (EU MDR)
Ref BCT081AModel EDTA K2 9.0ml
Identity
- Trade Name
- Sol-M Evacuated Blood Collection Tubes EUDAMED
- Model / Reference
- EDTA K2 9.0ml EUDAMEDBCT081A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809357961918 EUDAMED
- Basic UDI-DI
- B-08809357961918 EUDAMED
- EMDN Code
- W050101010201 BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
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
Sol-M Evacuated Blood Collection Tubes by AB Medical, Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08809357961918 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- AB Medical, Inc.
- EUDAMED SRN
- KR-MF-000026779
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED 72e7511a-5cbc-4885-8ca1-431e025c5d63 61 fields · synced Jun 18, 2026