Hot/Cold Pack
Ref 12.7*13.5cmModel 12.7*13.5cm, 15.3-22.9cm, 12.7*15.3cm, 15.3-22.9cm, 12.7*17.8cm, 17*25cm, 12.7*17.8cm, 12.7*25.4cm, 12*29cm, 10.2*24.5cm, 25.4*38.1cm, 7.6*22.6cm, 12.3*18.7cm, 20.5*38.5cm,10.5*26.5cm,13*18cm, 20.5*38.5cm,26*38cm,34*41cm,Custom-made.
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 | Number697407780HCP001GU 06974077804004 | Date1 Aug 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- Withdrawn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
- Hot/Cold Pack
- Model / Reference
- 12.7*13.5cm, 15.3-22.9cm, 12.7*15.3cm, 12.7*17.8cm, 17*25cm, 12.7*25.4cm, 12*29cm, 10.2*24.5cm, 25.4*38.1cm, 7.6*22.6cm, 12.3*18.7cm, 20.5*38.5cm, 10.5*26.5cm, 13*18cm, 26*38cm, 34*41cm, Custom-made.
- Primary DI / UDI-DI
- 06974077804004
- Basic UDI-DI
- 697407780HCP001GU
- EMDN Code
- M9001 Cryotherapy and thermotherapy devices
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000042779
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from JM Medical 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