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Infusion sets for single use with needle

EUDAMED

Class IIa (EU MDR)

Ref RYSY-CModel RYSY-A

by Shandong Ruyue Medical Technology Co., Ltd.

Identity

Device Name
Infusion sets for single use with needle EUDAMED
Model / Reference
RYSY-A EUDAMED
RYSY-C EUDAMED

Identifiers

Primary DI / UDI-DI
06942493600029 EUDAMED
Basic UDI-DI
69424936RYSY4R 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

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 with needle by Shandong Ruyue Medical Technology Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000041139
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED be8282d6-89b6-4457-9db7-509439ccccd0 61 fields · synced Jun 19, 2026