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cold therapy system/set/unit
EUDAMEDClass I (EU MDR)
Ref hipModel 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, EUDAMEDhip EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975803350505 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
cold therapy system/set/unit by Shanghai Youwen 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 | 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 17a2ebba-5b0b-4ba3-899a-32772aecf232 61 fields · synced Jun 18, 2026