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Sterile Infusion Sets for Single Use（with needle ）
EUDAMEDClass IIa (EU MDR)
Ref 6215
Identity
- Device Name
- Sterile Infusion Sets for Single Use（with needle ） EUDAMED
- Model / Reference
- 6215 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949230162154 EUDAMED
- Basic UDI-DI
- 69492301CGSYQ05VS EUDAMED
- EMDN Code
- A03010101 INFUSION CONTROLLERS WITH OR W/O AIR INLET EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterile Infusion Sets for Single Use（with needle ） by Jiangxi Yikang Medical Instrument Group Co., Ltd. — Class IIa — MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69492301CGSYQ05VS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangxi Yikang Medical Instrument Group Co., Ltd.
- EUDAMED SRN
- CN-MF-000030129
- Authorised Representative
- phoenix Medtech GmbH DE-AR-000007996
Sources (1)
- EUDAMED a6c51276-1d21-4a74-bba2-605729427efb 61 fields · synced Jun 19, 2026