Hot/cold pack / Ice packs / Reusable gel pack / Reusable instant ice pack / Cooling gel patch
by Hangzhou Weize Imp & Exp Co., Ltd. 22 variants
Ref HG-IP03Model HG-RP01, HG-RP02, HG-RP03, HG-RP04, HG-IP01, HG-IP02, HG-IP03, HG-IP04, HG-IP05, HG-IP06, HG-IP07, HG-IP08, HG-IP09, HG-IP10, HG-IP11, HG-IP12, HG-IP13, HG-IP14, HG-IP15, HG-IP16, HG-IP17, HG-IP18
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 | Number697654367IcepacksYU 06976543670588 | Date27 Mar 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- Withdrawn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
- Hot/cold pack / Ice packs / Reusable gel pack / Reusable instant ice pack / Cooling gel patch
- Model / Reference
- HG-RP01, HG-RP02, HG-RP03, HG-RP04, HG-IP01, HG-IP02, HG-IP03, HG-IP04, HG-IP05, HG-IP06, HG-IP07, HG-IP08, HG-IP09, HG-IP10, HG-IP11, HG-IP12, HG-IP13, HG-IP14, HG-IP15, HG-IP16, HG-IP17, HG-IP18
- Primary DI / UDI-DI
- 06976543670588
- Basic UDI-DI
- 697654367IcepacksYU
- EMDN Code
- M9001 Cryotherapy and thermotherapy devices
- Device Class
- Class I
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000036544
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Hangzhou Weize Imp & Exp 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