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Sterile Cover
EUDAMEDClass I (EU MDR)
Ref 9553Ref 9581Ref 9550Ref 9592Ref 9587Ref 9561
Identity
- Device Name
- Sterile Cover EUDAMED
- Model / Reference
- 9553 EUDAMED9581 EUDAMED9550 EUDAMED9592 EUDAMED9587 EUDAMED9561 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430033409534 EUDAMED06430033409817 EUDAMED06430033409503 EUDAMED06430033409923 EUDAMED06430033409879 EUDAMED06430033409619 EUDAMED
- Basic UDI-DI
- B-06430033409534 EUDAMEDB-06430033409817 EUDAMEDB-06430033409503 EUDAMEDB-06430033409923 EUDAMEDB-06430033409879 EUDAMEDB-06430033409619 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-06430033409534 | Class I | Active |
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Manufacturer
- Manufacturer
- Oy Fluorplast Ab
- EUDAMED SRN
- FI-MF-000015708
Sources (6)
- EUDAMED ebc7a6e1-2be1-4c4a-bd9d-cb8560ac43b5 61 fields · synced Jul 28, 2026
- EUDAMED 4dac9ec6-2318-41ad-afe6-9135fc6577b5 61 fields · synced May 17, 2026
- EUDAMED 62aef0e1-0264-4a93-a61f-1f58a34e9e12 61 fields · synced May 17, 2026
- EUDAMED 87e88dea-ed27-47a1-9de9-dec4324b9bf4 61 fields · synced May 17, 2026
- EUDAMED 4dd16b18-2da1-47e9-a3e7-05038fed0468 61 fields · synced May 18, 2026
- EUDAMED 32eb1859-90cb-40ed-983f-c52addb21c1e 61 fields · synced May 18, 2026