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Sterile Infusion Set for Single Use
EUDAMEDClass I (EU MDR)
Ref NAModel A-1 、B-1、A-3、B-4、B-9-2
Identity
- Device Name
- Sterile Infusion Set for Single Use EUDAMED
- Model / Reference
- A-1 、B-1、A-3、B-4、B-9-2 EUDAMEDNA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16933298297627 EUDAMED
- Basic UDI-DI
- 69332982001V4 EUDAMED
- EMDN Code
- A03010199 INFUSION CONTROLLERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria 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 Set for Single Use by Jiangsu Suyun Medical Materials Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69332982001V4 | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Suyun Medical Materials Co., Ltd.
- EUDAMED SRN
- CN-MF-000021132
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED a01cebe4-1430-43de-ace0-dab35b58b8dc 61 fields · synced Jul 15, 2026