Identity
- Trade Name
- EUPILEN EUDAMED
- Device Name
- EUPILEN - ES EUDAMED
- Model / Reference
- 8029408148772 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FPCAEU31SDX EUDAMED
- Basic UDI-DI
- B-FPCAEU31SDX EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Eupilen by UNIFARCO SpA — Class IIa — 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-FPCAEU31SDX | Class IIa | Active |
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Manufacturer
- Manufacturer
- UNIFARCO SpA
- EUDAMED SRN
- IT-MF-000013304
Sources (1)
- EUDAMED 86efd18c-0c5f-4c6c-9c69-325ef3d29753 61 fields · synced Jun 18, 2026