Identity
- Trade Name
- GEM Hemochron 100 EUDAMEDCentralized Configuration Manager Software FDA UDI
- Generic Name
- Coagulation analyser IVD, point-of-care, line-powered FDA UDI
- Device Name
- GEM® Hemochron™ 100 System Centralized Configuration Manager EUDAMEDCentralized Configuration Manager Software FDA UDI
- Model / Reference
- 000GCCM EUDAMEDFDA UDI
- Description
- Centralized Configuration Manager Software FDA UDI
Identifiers
- Catalog Number
- 000GCCM FDA UDI
- Primary DI / UDI-DI
- 10711234540121 EUDAMEDFDA UDI
- Basic UDI-DI
- 0711234540124NB EUDAMED
- 510(k) Number
- K202101 FDA UDI
- FDA Product Code
- JPA FDA UDI
- EMDN Code
- W0202020182 COAGULOMETERS - SOFTWARE ACCESSORIES 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
- Special Device Type
- Software EUDAMED
- 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
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
GEM Hemochron 100 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 | 0711234540124NB | 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 761ceb17-d2cc-4c40-8745-35d9a9e7b073 61 fields · synced Jun 8, 2026
- FDA UDI eab9b38f-dda5-4270-8e23-75f4f7ad28fc 36 fields · synced May 30, 2026