Identity
- Device Name
- Disposable Infusion Sets EUDAMED
- Model / Reference
- 001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975266040012 EUDAMED
- Basic UDI-DI
- B-06975266040012 EUDAMED
- EMDN Code
- A03010101 INFUSION CONTROLLERS WITH OR W/O AIR INLET 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
Disposable Infusion Sets by Shandong Qinkai Medical Industry Co.Ltd — 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-06975266040012 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shandong Qinkai Medical Industry Co.Ltd
- EUDAMED SRN
- CN-MF-000030489
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED 0a8db5c1-1132-4806-be83-31f79537f40f 61 fields · synced Oct 6, 2026