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STA® - Néoplastine® CI Plus 10
EUDAMEDFDA UDIClass C (EU MDR)
Ref 00667Model STA® - Néoplastine® CI Plus
Identity
- Trade Name
- STA® - Néoplastine® CI Plus 10 EUDAMEDFDA UDI
- Generic Name
- Prothrombin time (PT) IVD, kit, clotting FDA UDI
- Model / Reference
- STA® - Néoplastine® CI Plus EUDAMED00667 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03607450006674 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 10 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 |
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Manufacturer
- Manufacturer
- Diagnostica Stago
- EUDAMED SRN
- FR-MF-000017089
Sources (2)
- EUDAMED 9e60a7dd-baaf-42f7-bd5c-77517001784f 61 fields · synced Jul 12, 2026
- FDA UDI b91bbf9c-a8ef-45cc-84c5-95612901a75a 34 fields · synced May 30, 2026