Identity
- Trade Name
- GEM® Hemochron™ 100 System EUDAMEDGEM Hemochron 100 System FDA UDI
- Generic Name
- Coagulation analyser IVD, point-of-care, line-powered FDA UDI
- Device Name
- GEM® Hemochron™ 100 System EUDAMEDGEM Hemochron 100 System - GEM Hemochron 100 Instrument FDA UDI
- Model / Reference
- 000GH100 EUDAMEDFDA UDI
- Description
- GEM Hemochron 100 System - GEM Hemochron 100 Instrument FDA UDI
Identifiers
- Catalog Number
- 000GH100 FDA UDI
- Primary DI / UDI-DI
- 10711234515006 EUDAMEDFDA UDI
- Basic UDI-DI
- 0711234515009NC EUDAMED
- 510(k) Number
- K202101 FDA UDI
- FDA Product Code
- JPA FDA UDI
- EMDN Code
- W0202020101 SEMI-AUTOMATED COAGULOMETERS EUDAMED
- GMDN Term
- Coagulation analyser IVD, point-of-care, line-powered FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5425 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
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
GEM® Hemochron™ 100 System by Accriva Diagnostics, Inc. — Class A — 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 | 0711234515009NC | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Accriva Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000009902
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED c0070bc1-2f6b-4dc0-8e17-bfe9cc4155c5 61 fields · synced Jul 19, 2026
- FDA UDI aba4893c-6738-4938-9487-677e4e518c69 36 fields · synced May 30, 2026