Identity
- Device Name
- Sterile Cover EUDAMED
- Model / Reference
- 9583 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430033409831 EUDAMED
- Basic UDI-DI
- B-06430033409831 EUDAMED
- EMDN Code
- T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
Yes
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
Sterile Cover by Oy Fluorplast Ab — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-06430033409831 | Class I | Active |
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Manufacturer
- Manufacturer
- Oy Fluorplast Ab
- EUDAMED SRN
- FI-MF-000015708
Sources (1)
- EUDAMED bdb2cd2d-5a65-492b-963f-c40d6219d8de 61 fields · synced Jun 17, 2026