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Sterile Infusion Sets without Needles for Single Use
EUDAMEDClass I (EU MDR)
Ref IS4010Model IS40
Identity
- Trade Name
- Sterile Infusion Sets without Needles for Single Use EUDAMED
- Model / Reference
- IS40 EUDAMEDIS4010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935550815115 EUDAMED
- Basic UDI-DI
- 69355508BDZSYQ004W9 EUDAMED
- EMDN Code
- A03010103 INFUSION CONTROLLERS WITH FLOW REGULATOR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterile Infusion Sets without Needles for Single Use by Jiangsu Shenli Medical Production Co., Ltd. — 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 | 69355508BDZSYQ004W9 | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- EUDAMED SRN
- CN-MF-000029176
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED c5cdd551-dbee-42f5-9f1d-f520e9b6b338 61 fields · synced Jun 19, 2026