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cold therapy system/set/unit
EUDAMEDClass I (EU MDR)
Ref shoulderModel universal, hand, foot, knee, shoulder, head, wrist, waist, thigh, calf, hip, neck, back, elbow, ankle, Ref kneeRef headRef ankleRef neckRef waistRef elbowRef thighRef footRef hand
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, EUDAMEDshoulder EUDAMEDknee EUDAMEDhead EUDAMEDankle EUDAMEDneck EUDAMEDwaist EUDAMEDelbow EUDAMEDthigh EUDAMEDfoot EUDAMEDhand EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975803350444 EUDAMED06975803350437 EUDAMED06975803350451 EUDAMED06975803350543 EUDAMED06975803350512 EUDAMED06975803350475 EUDAMED06975803350536 EUDAMED06975803350482 EUDAMED06975803350420 EUDAMED06975803350413 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 (10)
- EUDAMED 52397ad4-95df-42f2-8e75-012b57546a14 61 fields · synced Aug 3, 2026
- EUDAMED e6ca5a48-e16f-4495-8a1e-bbbd8212173a 61 fields · synced May 16, 2026
- EUDAMED bda7521b-553c-40c5-a151-539475d6ecfd 61 fields · synced May 17, 2026
- EUDAMED 1e816c02-c17a-4fdb-8a00-7425f84a6a3b 61 fields · synced May 17, 2026
- EUDAMED daeed531-6afd-48dd-9f64-3191a175b808 61 fields · synced May 17, 2026
- EUDAMED dcb7db1f-8543-418e-8c22-bda55745aee8 61 fields · synced May 18, 2026
- EUDAMED 96821e51-ba09-4d77-871d-836e045ceb35 61 fields · synced May 18, 2026
- EUDAMED 31c8b340-f134-488b-8d7a-34f9057cde40 61 fields · synced May 19, 2026
- EUDAMED bf7c4c63-1e7f-4806-a28c-c1ff571b541f 61 fields · synced May 19, 2026
- EUDAMED d1652a0d-ad1d-4fdd-b9a2-216449660db7 61 fields · synced May 19, 2026