Identity
- Trade Name
- HemosIL Q.F.A. Thrombin (Bovine) EUDAMEDHemosIL Q.F.A. Thrombin (Bovine) - 5 mL FDA UDI
- Generic Name
- Fibrinogen assay (factor I) IVD, kit, clotting FDA UDI
- Device Name
- HemosIL Q.F.A. Thrombin (Bovine) EUDAMEDHemosIL Q.F.A. Thrombin (Bovine) - 5 mL FDA UDI
- Model / Reference
- 0020301700 EUDAMED00020301700 FDA UDI
- Description
- HemosIL Q.F.A. Thrombin (Bovine) - 5 mL FDA UDI
Identifiers
- Catalog Number
- 00020301700 FDA UDI
- Primary DI / UDI-DI
- 08426950573494 EUDAMEDFDA UDI
- Basic UDI-DI
- 84269505734949L EUDAMED
- Direct Marketing DI
- 08426950573494 EUDAMED
- 510(k) Number
- K963902 FDA UDI
- FDA Product Code
- GIS FDA UDI
- EMDN Code
- W0103020201 FIBRINOGEN ASSAYS (FACTOR I) EUDAMED
- GMDN Term
- Fibrinogen assay (factor I) IVD, kit, clotting FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7340 FDA UDI
- Market of Registration
- Italy 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
New Device
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
HemosIL Q.F.A. Thrombin (Bovine) by Instrumentation Laboratory Company — Class B — 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 | 84269505734949L | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Instrumentation Laboratory Company
- EUDAMED SRN
- US-MF-000035586
- Authorised Representative
- Instrumentation Laboratory SpA IT-AR-000008169
Sources (2)
- EUDAMED 0e543c57-f1fb-47e8-b26b-e3b7ebe2f6c8 61 fields · synced Oct 6, 2026
- FDA UDI f7b7356a-d7f0-49e2-ad5e-8836f751ccc1 37 fields · synced May 30, 2026