← Back to catalogue
TriniCLOT PT Excel S 20 mL
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref T1103Model TriniCLOT PT Excel S 20 mL
Identity
- Trade Name
- TriniCLOT PT Excel S 20 mL EUDAMEDTriniCLOT™ PT Excel S 20 mL FDA UDI
- Generic Name
- Prothrombin time (PT) IVD, kit, clotting FDA UDI
- Device Name
- TriniCLOT PT Excel S 20 mL EUDAMED
- Model / Reference
- TriniCLOT PT Excel S 20 mL EUDAMEDT1103 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05391521420251 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391521420251 EUDAMED
- 510(k) Number
- K882214 FDA UDI
- FDA Product Code
- GJS FDA UDI
- EMDN Code
- W0103020101 PROTHROMBIN TIME ( QUICK TEST ) EUDAMED
- GMDN Term
- Prothrombin time (PT) IVD, kit, clotting FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7750 FDA UDI
- Market of Registration
- Germany 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
Yes
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
TriniCLOT PT Excel S 20 mL 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-05391521420251 | 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 09fcadc5-dd78-44ba-95b7-32d9029d9253 61 fields · synced Jul 8, 2026
- FDA UDI de5c95ac-62ef-4d37-90b1-46968db848e1 34 fields · synced May 30, 2026