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sthemO Owren Koller M
EUDAMEDClass A (EU MDR)
Ref 01463Model sthemO Owren Koller
Identity
- Trade Name
- sthemO Owren Koller M EUDAMED
- Model / Reference
- sthemO Owren Koller EUDAMED01463 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 13607450014638 EUDAMED
- Basic UDI-DI
- 3607450AUXI0013RT EUDAMED
- Unit of Use DI
- 03607450014631 EUDAMED
- EMDN Code
- W0103020903 BUFFERS (HAEMOSTASIS) 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
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
sthemO Owren Koller M 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 | 3607450AUXI0013RT | Class A | Active |
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Manufacturer
- Manufacturer
- Diagnostica Stago
- EUDAMED SRN
- FR-MF-000017089
Sources (1)
- EUDAMED 0c9c0846-9e2f-452b-aca7-7a15a17bf4f0 61 fields · synced Jun 18, 2026