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cold therapy system/set/unit

EUDAMED

Class I (EU MDR)

Ref backModel universal, hand, foot, knee, shoulder, head, wrist, waist, thigh, calf, hip, neck, back, elbow, ankle,

by Shanghai Youwen Medical Technology Co., Ltd.

Identity

Device Name
cold therapy system/set/unit EUDAMED
Model / Reference
universal, hand, foot, knee, shoulder, head, wrist, waist, thigh, calf, hip, neck, back, elbow, ankle, EUDAMED
back EUDAMED

Identifiers

Primary DI / UDI-DI
06975803350529 EUDAMED
Basic UDI-DI
697580335YW04RQ EUDAMED
EMDN Code
V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

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

Category: Device sterilization/disinfection container, reusable

cold therapy system/set/unit by Shanghai Youwen Medical Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Device sterilization/disinfection container, reusable.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000047209
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED 5349eece-0333-43e3-b682-e6a231144bcc 61 fields · synced Jun 19, 2026