Identity
- Trade Name
- VerifyNow™ System EUDAMEDVerifyNow System FDA UDI
- Generic Name
- Platelet aggregation analyser IVD FDA UDI
- Device Name
- VerifyNow™ System Preventative Maintenance Kit EUDAMEDVerifyNow System Preventative Maintenance Kit FDA UDI
- Model / Reference
- 85062 EUDAMEDFDA UDI
- Description
- VerifyNow System Preventative Maintenance Kit FDA UDI
Identifiers
- Catalog Number
- 85062 FDA UDI
- Primary DI / UDI-DI
- 10711234150115 EUDAMEDFDA UDI
- Basic UDI-DI
- 0711234150118M7 EUDAMED
- 510(k) Number
- K992531 FDA UDI
- FDA Product Code
- JOZ FDA UDI
- EMDN Code
- W0202010202 SEMI-AUTOMATED HEMATOLOGY ANALYSERS EUDAMED
- GMDN Term
- Platelet aggregation analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5700 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
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
VerifyNow™ 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 | 0711234150118M7 | 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 5183b56d-31c7-4058-8cad-d966e8cf54e4 61 fields · synced Aug 2, 2026
- FDA UDI 2e1276fc-3d28-438d-8937-0d13d81cd4b4 36 fields · synced May 30, 2026