Identity
- Device Name
- Disposable infusion Set EUDAMED
- Model / Reference
- IS-V EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973905961735 EUDAMED
- Basic UDI-DI
- B-06973905961735 EUDAMED
- EMDN Code
- A03010103 INFUSION CONTROLLERS WITH FLOW REGULATOR EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable infusion Set by Shandong Chengwu Medical Products Factory — Class IIa — 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-06973905961735 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shandong Chengwu Medical Products Factory
- EUDAMED SRN
- CN-MF-000003370
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED e1ede1e0-21ab-4e71-b8e7-bf6fec66d97d 61 fields · synced Oct 6, 2026