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Essential Insufflation Filter/Tubing Set with Luer Lock
EUDAMEDClass IIa (EU MDR)
Ref PS3600A
Identity
- Trade Name
- Essential Insufflation Filter/Tubing Set with Luer Lock EUDAMED
- Device Name
- Essential Insufflation Filter/Tubing Set with Luer Lock EUDAMED
- Model / Reference
- PS3600A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051223037538 EUDAMED
- Basic UDI-DI
- B-05051223037538 EUDAMED
- EMDN Code
- K0180 ENDOTHERAPY DEVICES - OTHER ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa 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 Insufflation Filter/Tubing Set with Luer Lock by Shandong Zhenfu Medical Device Co., Ltd. — Class IIa — MDD — listed in EUDAMED
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-05051223037538 | Class IIa | 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 c9cef47c-7ab1-4350-a6d3-b8b9a45e9835 61 fields · synced Jun 18, 2026