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TriniCLOT APTT S 10ML
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref T1201Model TriniCLOT APTT S 10ML
Identity
- Trade Name
- TriniCLOT APTT S 10ML EUDAMEDTriniCLOT™ aPTT S 10 mL FDA UDI
- Generic Name
- Activated partial thromboplastin time (APTT) IVD, kit, clotting FDA UDI
- Device Name
- TriniCLOT APTT S 10ML EUDAMED
- Model / Reference
- TriniCLOT APTT S 10ML EUDAMEDT1201 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05391521420299 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391521420299 EUDAMED
- 510(k) Number
- K921396 FDA UDI
- FDA Product Code
- GFO FDA UDI
- EMDN Code
- W0103020102 ACTIVATED PARTIAL THROMBOPLASTIN TIME EUDAMED
- GMDN Term
- Activated partial thromboplastin time (APTT) IVD, kit, clotting FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7925 FDA UDI
- Market of Registration
- Spain 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 APTT S 10ML 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-05391521420299 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Tcoag ireland ltd
- EUDAMED SRN
- IE-MF-000027371
Sources (2)
- EUDAMED 2012356d-f9d8-4926-93af-242d1d331972 61 fields · synced Jul 16, 2026
- FDA UDI 6b6bad37-2a36-4844-bb47-2bc5595102a6 34 fields · synced May 30, 2026