Hot Cold Pack
by Wuhan Pakcare Bio‐technology Co., Ltd. 6 variants
Ref BFQM01Model 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 | Number697892097HP100Q6 06978920973169 | Date12 May 2026 | 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- Withdrawn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
- AMRD01, BFQM01
- Primary DI / UDI-DI
- 06978920973169
- Basic UDI-DI
- 697892097HP100Q6
- Direct Marketing DI
- 06978920973169
- EMDN Code
- M9001 Cryotherapy and thermotherapy devices
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000008960
- Authorised representative
- Share info GmbH DE-AR-000005132
Other devices from Wuhan Pakcare Bio‐technology Co., Ltd.
See all devices from Wuhan Pakcare Bio‐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