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Sol-M Evacuated Blood Collection Tubes
EUDAMEDClass IVD General (EU MDR)
Ref BCT033AModel Clot Activator with Gel 3.5mlRef BCT063AModel Lithium Heparin and Gel 3.5mlRef BCT082AModel EDTA K2 6.0mlRef BCT022AModel Clot Activator 6.0mlRef BCT011AModel No Additive 9.0mlRef BCT101AModel EDTA K3 with Gel 5.0mlRef BCT112AModel Trisodium Citrate 0.109M 1.8mlRef BCT062AModel Lithium Heparin and Gel 5.0mlRef BCT023AModel Clot Activator 4.0mlRef BCT052AModel Lithium Heparin 6.0mlRef BCT111AModel Trisodium Citrate 0.109M 2.7mlRef BCT094AModel EDTA K3 3.0mlRef BCT083AModel EDTA K2 4.0mlRef BCT013AModel No Additive 4.0mlRef BCT053AModel Lithium Heparin 4.0mlRef BCT012AModel No Additive 6.0mlRef BCT091AModel EDTA K3 9.0mlRef BCT102AModel EDTA K3 with Gel 3.5ml
Identity
- Trade Name
- Sol-M Evacuated Blood Collection Tubes EUDAMED
- Model / Reference
- Clot Activator with Gel 3.5ml EUDAMEDBCT033A EUDAMEDLithium Heparin and Gel 3.5ml EUDAMEDBCT063A EUDAMEDEDTA K2 6.0ml EUDAMEDBCT082A EUDAMEDClot Activator 6.0ml EUDAMEDBCT022A EUDAMEDNo Additive 9.0ml EUDAMEDBCT011A EUDAMEDEDTA K3 with Gel 5.0ml EUDAMEDBCT101A EUDAMEDTrisodium Citrate 0.109M 1.8ml EUDAMEDBCT112A EUDAMEDLithium Heparin and Gel 5.0ml EUDAMEDBCT062A EUDAMEDClot Activator 4.0ml EUDAMEDBCT023A EUDAMEDLithium Heparin 6.0ml EUDAMEDBCT052A EUDAMEDTrisodium Citrate 0.109M 2.7ml EUDAMEDBCT111A EUDAMEDEDTA K3 3.0ml EUDAMEDBCT094A EUDAMEDEDTA K2 4.0ml EUDAMEDBCT083A EUDAMEDNo Additive 4.0ml EUDAMEDBCT013A EUDAMEDLithium Heparin 4.0ml EUDAMEDBCT053A EUDAMEDNo Additive 6.0ml EUDAMEDBCT012A EUDAMEDEDTA K3 9.0ml EUDAMEDBCT091A EUDAMEDEDTA K3 with Gel 3.5ml EUDAMEDBCT102A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809357961505 EUDAMED08809357961895 EUDAMED08809357961925 EUDAMED08809357961666 EUDAMED08809357962151 EUDAMED08809357961970 EUDAMED08809357961604 EUDAMED08809357961888 EUDAMED08809357961499 EUDAMED08809357961840 EUDAMED08809357961673 EUDAMED08809357961482 EUDAMED08809357961932 EUDAMED08809357962113 EUDAMED08809357961833 EUDAMED08809357962045 EUDAMED08809357961949 EUDAMED08809357961987 EUDAMED
- Basic UDI-DI
- B-08809357961505 EUDAMEDB-08809357961895 EUDAMEDB-08809357961925 EUDAMEDB-08809357961666 EUDAMEDB-08809357962151 EUDAMEDB-08809357961970 EUDAMEDB-08809357961604 EUDAMEDB-08809357961888 EUDAMEDB-08809357961499 EUDAMEDB-08809357961840 EUDAMEDB-08809357961673 EUDAMEDB-08809357961482 EUDAMEDB-08809357961932 EUDAMEDB-08809357962113 EUDAMEDB-08809357961833 EUDAMEDB-08809357962045 EUDAMEDB-08809357961949 EUDAMEDB-08809357961987 EUDAMED
- EMDN Code
- W050101010201 BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR EUDAMEDW050101010202 BLOOD COLLECTION, TUBES WITHOUT 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-08809357961505 | 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 (18)
- EUDAMED 050b793f-17c1-4932-b6e3-d5a6e088f0f3 61 fields · synced Jul 31, 2026
- EUDAMED b1239395-6f4f-4412-99f6-b1e1307723fe 61 fields · synced May 16, 2026
- EUDAMED 0fadd514-4ee6-4913-b21b-7718c837c8db 61 fields · synced May 16, 2026
- EUDAMED f50459dc-045d-4018-8598-a3aa1457a6fa 61 fields · synced May 17, 2026
- EUDAMED 10cb47dd-a26f-43b4-ab55-f438c67d6d9c 61 fields · synced May 17, 2026
- EUDAMED a4764af6-c9a2-48f8-953f-8e4dc8f9984f 61 fields · synced May 17, 2026
- EUDAMED 3c9ac5a9-c97d-4e1b-b22d-90fe39d80e7b 61 fields · synced May 17, 2026
- EUDAMED 420d2f9c-03f7-408d-a26c-becb510ec299 61 fields · synced May 18, 2026
- EUDAMED da9bf88e-1d40-4e6d-8386-433914e5d619 61 fields · synced May 18, 2026
- EUDAMED d96611c5-6cab-48e5-b06c-830b9b9fe5c2 61 fields · synced May 18, 2026
- EUDAMED 9dbe0c8d-3d05-4c2d-95bb-c1fbdee71f67 61 fields · synced May 18, 2026
- EUDAMED 035527a6-a567-4cc4-a0a7-28a1c3df5f08 61 fields · synced May 18, 2026
- EUDAMED 3a96fd71-6134-4403-916d-16c34cc2ae9c 61 fields · synced May 18, 2026
- EUDAMED 76cfb526-0316-42c9-8963-7466b563b505 61 fields · synced May 18, 2026
- EUDAMED e48dcbb9-8b32-41c0-8a3f-a5b91571254b 61 fields · synced May 18, 2026
- EUDAMED 99b08a16-e4e1-4591-9397-49a9d6abc165 61 fields · synced May 18, 2026
- EUDAMED 252bf483-a498-4126-95b4-a3ca4f686453 61 fields · synced May 19, 2026
- EUDAMED dc3c60ba-1d4b-4725-90ea-a13817d68956 61 fields · synced Jul 15, 2026