Identity
- Trade Name
- HemosIL Liquid Anti-Xa EUDAMEDFDA UDI
- Generic Name
- Heparin anti-Xa IVD, kit, chromogenic FDA UDI
- Device Name
- HemosIL Liquid Anti-Xa EUDAMEDFDA UDI
- Model / Reference
- 00020302601 EUDAMED00020302600 FDA UDI
- Description
- HemosIL Liquid Anti-Xa FDA UDI
Identifiers
- Catalog Number
- 00020302600 FDA UDI
- Primary DI / UDI-DI
- 08426950808855 EUDAMED08426950580324 FDA UDI
- Basic UDI-DI
- 84269508088559T EUDAMED
- Direct Marketing DI
- 08426950808855 EUDAMED
- FDA Product Code
- KFF FDA UDI
- EMDN Code
- W0103020309 ANTI XA ACTIVITY FOR HEPARIN AND DOAC EUDAMED
- GMDN Term
- Heparin anti-Xa IVD, kit, chromogenic FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7525 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
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
No
FDA UDI
Category: Heparin anti-Xa IVD, kit, chromogenic
HemosIL Liquid Anti-Xa by Instrumentation Laboratory Company — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Heparin anti-Xa IVD, kit, chromogenic.
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Instrumentation Laboratory Company
Sources (2)
- FDA UDI 2b6b0a4a-c78f-4c88-a075-8f500b9d9c5b 37 fields · synced Jul 9, 2026
- EUDAMED 74794458-ed18-4c43-8cdc-15cb142f1e6d 61 fields · synced Jul 9, 2026