Hot & Cold Compress Gel Packs
by Wuhan Pakcare Bio‐technology Co., Ltd.
Ref /Model AGFX03, C502B0
Active
CE MDR CE MDD
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 | NumberB-06973589091247 06973589091247 | Date20 Feb 2024 | StatusActive |
| European Union | CE/MDD | NumberB-06973589091247 06973589091247 | Date20 Feb 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- Withdrawn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, CE/MDD Active
Specification
- Device Name
- Reusable Hot/cold packs
- Model / Reference
- AGFX03, /, C502B0
- Primary DI / UDI-DI
- 06973589091247
- Basic UDI-DI
- B-06973589091247, 697358909HP100MD
- Direct Marketing DI
- 06973589091247
- 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