Shin Gel Pack
by Wuhan Pakcare Bio‐technology Co., Ltd.
Part of a family of 312 devices: see the family page
Ref /Model AGHX11, C502B0
Shin Gel Pack (AGHX11) is a Class I device made by Wuhan Pakcare Bio‐technology Co., Ltd., registered in EUDAMED on 21 Feb 2024 (Basic UDI-DI B-06973589091193), active as of 22 Oct 2026.
Active
CE MDR CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberB-06973589091193 06973589091193 | Date21 Feb 2024 | StatusActive |
| European Union | CE/MDD | NumberB-06973589091193 06973589091193 | Date21 Feb 2024 | StatusActive |
Official records
- EUDAMED public site B-06973589091193
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- Withdrawn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
- AGHX11, /, C502B0
- Primary DI / UDI-DI
- 06973589091193
- Basic UDI-DI
- B-06973589091193, 697358909HP100MD
- Direct marketing DI
- 06973589091193
- EMDN code
- M9001 Cryotherapy and thermotherapy devices
- Device class
- Class I
- System or procedure pack
- Procedure pack which is a device in itselfSystem which is a device in itself
- EU registration type
- Legacy device (under a directive)Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000008960
- Authorised representative
- Share info GmbH DE-AR-000005132
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Other devices from Wuhan Pakcare Bio‐technology Co., Ltd.
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