← Back to catalogue
STA® - Néoplastine® CI Plus 5
EUDAMEDFDA UDIClass C (EU MDR)
Ref 00606Model STA® - Néoplastine® CI Plus
Identity
- Trade Name
- STA® - Néoplastine® CI Plus 5 EUDAMEDFDA UDI
- Generic Name
- Prothrombin time (PT) IVD, kit, clotting FDA UDI
- Model / Reference
- STA® - Néoplastine® CI Plus EUDAMED00606 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03607450006063 EUDAMEDFDA UDI
- Basic UDI-DI
- 360745099PT00017M EUDAMED
- 510(k) Number
- K922040 FDA UDI
- FDA Product Code
- GJS FDA UDI
- EMDN Code
- W0103020101 PROTHROMBIN TIME ( QUICK TEST ) EUDAMED
- GMDN Term
- Prothrombin time (PT) IVD, kit, clotting FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7750 FDA UDI
- Market of Registration
- France 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
Yes
FDA UDI
STA® - Néoplastine® CI Plus 5 by Diagnostica Stago — Class C — 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 | 360745099PT00017M | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diagnostica Stago
- EUDAMED SRN
- FR-MF-000017089
Sources (2)
- EUDAMED 6fa12938-3c6f-47f9-95da-4c241fd21dfc 61 fields · synced Jun 18, 2026
- FDA UDI b6d47916-0ef5-49b3-8886-a969c5cfc84d 34 fields · synced May 30, 2026