HOT/COLD PACK Gel pack, over large size
by Wuhan Pakcare Bio‐technology Co., Ltd.
Ref AGFX51Model C502B0, AMRD01
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 | Number697358909HP100MD 06978920970045 | Date6 Jan 2023 | 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- Withdrawn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
- Reusable Hot/cold packs
- Model / Reference
- C502B0, AGFX51, AMRD01
- Primary DI / UDI-DI
- 06978920970045
- Basic UDI-DI
- 697358909HP100MD, 697892097HP100Q6
- Direct Marketing DI
- 06978920970045
- EMDN Code
- M9001 Cryotherapy and thermotherapy devices
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000008960
- Authorised representative
- Share info GmbH DE-AR-000005132
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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