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TransFix/EDTA 3 mL Vacuum Blood Collection Tubes (2 tubes)
EUDAMEDClass IVD General (EU MDR)
Ref TVT-03-2
Identity
- Device Name
- TransFix/EDTA 3 mL Vacuum Blood Collection Tubes (2 tubes) EUDAMED
- Model / Reference
- TVT-03-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 45060531711601 EUDAMED
- Basic UDI-DI
- B-45060531711601 EUDAMED
- EMDN Code
- W050101010201 BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
TransFix/EDTA 3 mL Vacuum Blood Collection Tubes (2 tubes) by Caltag Medsystems Ltd — Class IVD General — IVDD — listed in EUDAMED
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-45060531711601 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Caltag Medsystems Ltd
- EUDAMED SRN
- GB-MF-000021669
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 917a9f94-2ed7-4abb-97ae-ff0c65aeb6b6 61 fields · synced Jun 18, 2026