Identity
- Device Name
- Infusion Sets for Single Use EUDAMED
- Model / Reference
- many EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-IV8M EUDAMED
- Basic UDI-DI
- B-IV8M EUDAMED
- EMDN Code
- A03010102 INFUSION CONTROLLERS WITH FILTER (ALSO TRANSFUSION CONTROLLERS) 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Infusion Sets for Single Use by Jiangsu Kangjin Medical Instrument 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-IV8M | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangsu Kangjin Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000011142
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 80f2cb23-77af-43dc-8de0-54ec6993dd27 61 fields · synced Jul 22, 2026