← Back to catalogue
TriniCHROM Factor VIII:c
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref T2608Model TriniCHROM Factor VIII:c
Identity
- Trade Name
- TriniCHROM Factor VIII:c EUDAMEDTriniCHROM™ Factor VIII:C FDA UDI
- Generic Name
- Coagulation factor VIII IVD, kit, clotting FDA UDI
- Device Name
- TriniCHROM Factor VIII:c EUDAMED
- Model / Reference
- TriniCHROM Factor VIII:c EUDAMEDT2608 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05391521420565 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391521420565 EUDAMED
- 510(k) Number
- K934584 FDA UDI
- FDA Product Code
- GGP FDA UDI
- EMDN Code
- W0103020207 COAGULATION FACTOR VIII EUDAMED
- GMDN Term
- Coagulation factor VIII IVD, kit, clotting FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7290 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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
TriniCHROM Factor VIII:c by Tcoag ireland ltd — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-05391521420565 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tcoag ireland ltd
- EUDAMED SRN
- IE-MF-000027371
Sources (2)
- EUDAMED e9edb267-6f68-4610-b2d9-5f05f158de65 61 fields · synced Jun 18, 2026
- FDA UDI 0da7438f-0345-4372-9b68-5a5dbbc38983 34 fields · synced May 30, 2026