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Light-resistant infusion sets for single use with needle
EUDAMEDClass IIa (EU MDR)
Ref BGSY-HModel BGSY-A,BGSY-B,BGSY-C,BGSY-D,BGSY-E,BGSY-F,BGSY-G,BGSY-H
Identity
- Trade Name
- Light-resistant infusion sets for single use with needle EUDAMED
- Device Name
- Light-resistant infusion sets for single use with needle EUDAMED
- Model / Reference
- BGSY-A,BGSY-B,BGSY-C,BGSY-D,BGSY-E,BGSY-F,BGSY-G,BGSY-H EUDAMEDBGSY-H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942493600630 EUDAMED
- Basic UDI-DI
- 69424936BGSYWC EUDAMED
- EMDN Code
- A03010101 INFUSION CONTROLLERS WITH OR W/O AIR INLET EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Light-resistant infusion sets for single use with needle by Shandong Ruyue Medical Technology 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 | 69424936BGSYWC | Class IIa | 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 1f8a9ffc-cbad-49a8-8dc8-cb0842b9458e 61 fields · synced Jun 19, 2026