Identity
- Device Name
- TransFix CSF Sample Storage Tube EUDAMED
- Model / Reference
- TF-CSF-S-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 35060531710058 EUDAMED
- Basic UDI-DI
- 506053171CSFCG EUDAMED
- Direct Marketing DI
- 35060531710058 EUDAMED
- EMDN Code
- W050301020101 SAMPLES ANALYSES, PLASTIC TUBES WITH ADDITIVES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: General specimen collection kit
TransFix CSF Sample Storage Tube by Caltag Medsystems Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 506053171CSFCG | Class A | 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 2167cd9e-8557-41f5-87ef-b42e7a68ff99 61 fields · synced Jul 24, 2026