Identity
- Device Name
- Sterile Cover Bag EUDAMED
- Model / Reference
- 9510 EUDAMED9515 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430033409107 EUDAMED06430033409152 EUDAMED
- Basic UDI-DI
- B-06430033409107 EUDAMEDB-06430033409152 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 Bag 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-06430033409107 | Class I | Active |
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Manufacturer
- Manufacturer
- Oy Fluorplast Ab
- EUDAMED SRN
- FI-MF-000015708
Sources (2)
- EUDAMED 25d6d59c-31fe-425f-a213-9276d41e1a5f 61 fields · synced Jul 14, 2026
- EUDAMED 0f95ec93-b23d-4c0e-80bc-fabe63206bb7 61 fields · synced May 16, 2026