Identity
- Trade Name
- STA® - ECA II EUDAMED
- Device Name
- STA® - ECA II EUDAMED
- Model / Reference
- 00992 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03607450009927 EUDAMED
- Basic UDI-DI
- 3607450AIIA0001AD EUDAMED
- EMDN Code
- W0103020310 ANTI IIA ACTIVITY FOT DOAC EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Sta® - Eca Ii by Diagnostica Stago — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 3607450AIIA0001AD | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diagnostica Stago
- EUDAMED SRN
- FR-MF-000017089
Sources (1)
- EUDAMED 986fc153-da34-441d-ad31-6019d965d4b5 61 fields · synced Jul 11, 2026