cold therapy pad/wrap
by Huaian Youwen Medical Technology Co., Ltd.
Ref thighModel thigh,calf,wrist,elbow,knee,waist,ankle,shoulder,head,face,lower face,jaw,breast,blanket,arm,hip
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697326121coldtherapyFS 06973261210003 | Date22 Aug 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- cold therapy pad/wrap
- Model / Reference
- thigh, calf, wrist, elbow, knee, waist, ankle, shoulder, head, face, lower face, jaw, breast, blanket, arm, hip
- Primary DI / UDI-DI
- 06973261210003
- Basic UDI-DI
- 697326121coldtherapyFS
- EMDN Code
- M9001 Cryotherapy and thermotherapy devices
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000049185
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Huaian Youwen Medical Technology Co., Ltd.
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No