Identity
- Trade Name
- TransFix 20ml EUDAMEDTransFix FDA UDI
- Generic Name
- Cell preservation/storage/dilution solution IVD FDA UDI
- Device Name
- TransFix and TransFix Sample Storage Tubes EUDAMED
- Model / Reference
- TFB-20-1 EUDAMEDTFB-20 FDA UDI
Identifiers
- Catalog Number
- TFB-20-1 FDA UDI
- Primary DI / UDI-DI
- 05060531710019 EUDAMEDFDA UDI
- Basic UDI-DI
- 506053171TFBSST7P EUDAMED
- FDA Product Code
- PPM FDA UDI
- EMDN Code
- W0103080699 REAGENTS FOR FLOW CYTOMETRY - OTHER EUDAMED
- GMDN Term
- Cell preservation/storage/dilution solution IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4010 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
TransFix 20ml by Caltag Medsystems Ltd — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 506053171TFBSST7P | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Caltag Medsystems Ltd
- EUDAMED SRN
- GB-MF-000021669
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 6212a0e5-a652-42ec-b2a2-a6f8e832b122 61 fields · synced Jun 18, 2026
- FDA UDI d6beb4e6-4e70-49c4-871e-9513902b1438 34 fields · synced May 30, 2026