Identity
- Trade Name
- Sulfax Optima EUDAMED
- Device Name
- Sulfax Optima (50 ml) EUDAMED
- Model / Reference
- 800_571 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06418029906144 EUDAMED
- Basic UDI-DI
- B-06418029906144 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Device sterilization/disinfection container, reusable
Sulfax Optima by Fysioline Oy — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06418029906144 | Class I | Active |
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Manufacturer
- Manufacturer
- Fysioline Oy
- EUDAMED SRN
- FI-MF-000001173
Sources (1)
- EUDAMED 5fe43366-fe01-46c1-9690-1882c3bfaaac 61 fields · synced Jun 17, 2026