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Infusion sets for single use
EUDAMEDClass I (EU MDR)
Ref WZSY-HModel WZSY-A,WZSY-B,WZSY-C,WZSY-D,WZSY-E,WZSY-F,WZSY-G,WZSY-H
Identity
- Trade Name
- Infusion sets for single use EUDAMED
- Device Name
- Infusion sets for single use EUDAMED
- Model / Reference
- WZSY-A,WZSY-B,WZSY-C,WZSY-D,WZSY-E,WZSY-F,WZSY-G,WZSY-H EUDAMEDWZSY-H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942493600234 EUDAMED
- Basic UDI-DI
- 69424936WZSY5Z EUDAMED
- EMDN Code
- A03010101 INFUSION CONTROLLERS WITH OR W/O AIR INLET EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Infusion sets for single use by Shandong Ruyue Medical Technology 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 | 69424936WZSY5Z | Class I | Active |
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Manufacturer
- Manufacturer
- Shandong Ruyue Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000041139
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 8e43586f-0c60-48cc-a58c-e58648c0766b 61 fields · synced Jun 19, 2026