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TransFix and TransFix Sample Storage Tubes
EUDAMEDClass A (EU MDR)
Ref TFB-01-10
Identity
- Device Name
- TransFix and TransFix Sample Storage Tubes EUDAMED
- Model / Reference
- TFB-01-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 25060531710020 EUDAMED
- Basic UDI-DI
- 506053171TFBSST7P EUDAMED
- Direct Marketing DI
- 25060531710020 EUDAMED
- EMDN Code
- W0103080699 REAGENTS FOR FLOW CYTOMETRY - OTHER 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
Yes
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
TransFix and TransFix Sample Storage Tubes by Caltag Medsystems Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 506053171TFBSST7P | 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 57a9e8d1-0506-4d70-af6a-25e5151f981b 61 fields · synced Jun 18, 2026