Identity
- Trade Name
- sthemO 201 EUDAMED
- Device Name
- sthemO 201 EUDAMED
- Model / Reference
- 59032 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03607450590326 EUDAMED
- Basic UDI-DI
- 3607450INST0001UD EUDAMED
- Direct Marketing DI
- 03607450590326 EUDAMED
- EMDN Code
- W0202029099 VARIOUS HEMOSTASIS INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Yes
EUDAMED
New Device
No
EUDAMED
sthemO 201 by Diagnostica Stago — Class A — 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 | 3607450INST0001UD | Class A | 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 2270f3cd-f7bb-40a6-a70b-6e579e1abb5b 61 fields · synced Sep 17, 2026