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TriniCHROM Antithrombin IIa
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref T2602Model TriniCHROM Antithrombin IIa
Identity
- Trade Name
- TriniCHROM Antithrombin IIa EUDAMEDTriniCHROM™ Antithrombin IIa FDA UDI
- Generic Name
- Antithrombin III (ATIII) IVD, kit, chromogenic FDA UDI
- Device Name
- TriniCHROM Antithrombin IIa EUDAMED
- Model / Reference
- TriniCHROM Antithrombin IIa EUDAMEDT2602 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05391521420534 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391521420534 EUDAMED
- 510(k) Number
- K972144 FDA UDI
- FDA Product Code
- JBQ FDA UDI
- EMDN Code
- W0103020602 ANTITHROMBIN EUDAMED
- GMDN Term
- Antithrombin III (ATIII) IVD, kit, chromogenic FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7060 FDA UDI
- Market of Registration
- Netherlands 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
TriniCHROM Antithrombin IIa 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-05391521420534 | 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 a565751e-de9a-4cfd-9420-7cf23fb73cbc 61 fields · synced Jul 15, 2026
- FDA UDI 7485e036-7216-4f61-a07e-2ec95a7c2602 34 fields · synced May 30, 2026