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cold therapy system/set/unit
EUDAMEDClass I (EU MDR)
Ref wristModel universal, hand, foot, knee, shoulder, head, wrist, waist, thigh, calf, hip, neck, back, elbow, ankle,
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, EUDAMEDwrist EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975803350468 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
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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 | 697580335YW04RQ | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Youwen Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000047209
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 0ebec860-cec1-45ce-a206-713833dbc6a1 61 fields · synced Jun 19, 2026