Identity
- Device Name
- 9054 EUDAMED
- Model / Reference
- 9054 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430033400135 EUDAMED
- Basic UDI-DI
- B-06430033400135 EUDAMED
- EMDN Code
- A06010199 VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
For 9054, a Class IIa medical device manufactured by Oy Fluorplast Ab, this directory provides detailed information on its purpose, testing, and regulatory compliance. It also offers insights into the manufacturing process, sterilization methods, and more.
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-06430033400135 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Oy Fluorplast Ab
- EUDAMED SRN
- FI-MF-000015708
Sources (1)
- EUDAMED 4b6d0b6a-5680-4786-b977-beea58761768 61 fields · synced Jul 31, 2026