Identity
- Trade Name
- sthemA CTR-L2 EUDAMED
- Model / Reference
- sthemA CTR EUDAMED01402 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 13607450014027 EUDAMED
- Basic UDI-DI
- 3607450CTLS0023R5 EUDAMED
- Unit of Use DI
- 03607450014020 EUDAMED
- EMDN Code
- W0103010599 HAEMATOLOGY CONTROLS - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
sthemA CTR-L2 by Diagnostica Stago — Class B — 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 | 3607450CTLS0023R5 | Class B | Active |
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Manufacturer
- Manufacturer
- Diagnostica Stago
- EUDAMED SRN
- FR-MF-000017089
Sources (1)
- EUDAMED 0c4f6dca-1b04-42c2-b18e-c8fe9c1d9643 61 fields · synced Jun 19, 2026