Heat Patch
by Hebei Yinuan Biotechnology Co., Ltd. 10 variants
Ref Steam eye maskModel Steam eye mask、warm Patch、Body warmer、Hand warmer、Foot warmer、Toe warmer、Steam neck warmer、Steam knee warmer、 Steam waist warmer、Steam Foot warmer、Steam Hand warmer
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 | Number697785139HotpatchH6 06977851390021 | Date15 Nov 2024 | 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- Withdrawn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
- Heat Patch
- Model / Reference
- Steam eye mask、warm Patch、Body warmer、Hand warmer、Foot warmer、Toe warmer、Steam neck warmer、Steam knee warmer、 Steam waist warmer、Steam Foot warmer、Steam Hand warmer, Steam eye mask
- Primary DI / UDI-DI
- 06977851390021
- Basic UDI-DI
- 697785139HotpatchH6
- EMDN Code
- M9001 Cryotherapy and thermotherapy devices
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000043845
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Hebei Yinuan Biotechnology 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