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Infusion Set for Single Use, Auto-Stop Valve + Auto-Prime cap with Injection si…
EUDAMEDClass I (EU MDR)
Ref Ins-1205Model Infusion Set for Single Use, Auto-Stop Valve
Identity
- Trade Name
- Infusion Set for Single Use, Auto-Stop Valve + Auto-Prime cap with Injection site Protector, PVC tubing EUDAMED
- Device Name
- Infusion Set for Single Use EUDAMED
- Model / Reference
- Infusion Set for Single Use, Auto-Stop Valve EUDAMEDIns-1205 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16955356113441 EUDAMED
- Basic UDI-DI
- 69553561INSZDY8 EUDAMED
- Direct Marketing DI
- 16955356113441 EUDAMED
- EMDN Code
- A03040199 INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Infusion Set for Single Use, Auto-Stop Valve + Auto-Prime cap with Injection si… by Gemtier Medical (Shanghai) Inc. — Class I — 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 | 69553561INSZDY8 | Class I | Active |
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Manufacturer
- Manufacturer
- Gemtier Medical (Shanghai) Inc.
- EUDAMED SRN
- CN-MF-000003835
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED e27c4d19-9cea-43d5-9971-b466c0b4a236 61 fields · synced Jul 10, 2026