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TransFix/EDTA 9 mL Vacuum Blood Collection Tubes (2 tubes)

EUDAMED

Class IVD General (EU MDR)

Ref TVT-09-2

by Caltag Medsystems Ltd

Identity

Device Name
TransFix/EDTA 9 mL Vacuum Blood Collection Tubes (2 tubes) EUDAMED
Model / Reference
TVT-09-2 EUDAMED

Identifiers

Primary DI / UDI-DI
45060531711618 EUDAMED
Basic UDI-DI
B-45060531711618 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 9 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

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Manufacturer

EUDAMED SRN
GB-MF-000021669
Authorised Representative
Advena Limited MT-AR-000000234

Sources (1)

  • EUDAMED 90db6727-7423-4ab8-a67a-407e8f76ad81 61 fields · synced Jun 18, 2026