Identity
- Trade Name
- Cardiac Marker Control VS FDA UDI
- Generic Name
- Multiple cardiac marker IVD, control FDA UDI
- Device Name
- Cardiac Marker Control VS EUDAMEDCardiac Marker Control VS Tri-Levels FDA UDI
- Model / Reference
- 91474 EUDAMEDFDA UDI
- Description
- Cardiac Marker Control VS Tri-Levels FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817238010042 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00817238010042 EUDAMED
- 510(k) Number
- K062916 FDA UDI
- FDA Product Code
- JJY FDA UDI
- EMDN Code
- W0101050201 ENZYME CONTROLS EUDAMED
- GMDN Term
- Multiple cardiac marker IVD, control FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Market of Registration
- Austria 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
No
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
Cardiac Marker Control VS by Cliniqa Corporation — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00817238010042 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Cliniqa Corporation
- EUDAMED SRN
- US-MF-000023908
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED b6c54461-d383-4285-b585-5b6ade235421 61 fields · synced Jul 9, 2026
- FDA UDI 45039e64-620b-458d-9b60-9c9955ad86da 34 fields · synced May 30, 2026