Identity
- Trade Name
- Essential Smoke Filter EUDAMED
- Device Name
- Essential Smoke Filter EUDAMED
- Model / Reference
- PS3604A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051223037583 EUDAMED
- Basic UDI-DI
- B-05051223037583 EUDAMED
- EMDN Code
- K02010107 SMOKE EVACUATION SYSTEMS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Essential Smoke Filter by Shandong Zhenfu Medical Device Co., Ltd. — 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-05051223037583 | Class I | Active |
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Manufacturer
- Manufacturer
- Shandong Zhenfu Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000031319
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED a4b177de-fb6c-418b-bd92-b32b8a073348 61 fields · synced Jul 23, 2026