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Hot Or Cold Gel Pack, Mini Size
EUDAMEDClass I (EU MDR)
Ref AGFX47Model C502B0Ref /
Identity
- Trade Name
- HOT OR COLD GEL PACK, MINI SIZE EUDAMED
- Device Name
- Reusable Hot/cold packs EUDAMEDHOT OR COLD GEL PACK, MINI SIZE EUDAMED
- Model / Reference
- C502B0 EUDAMEDAGFX47 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973589091766 EUDAMED
- Basic UDI-DI
- 697358909HP100MD EUDAMEDB-06973589091766 EUDAMED
- Direct Marketing DI
- 06973589091766 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Hot/cold therapy pack, reusable
Hot Or Cold Gel Pack, Mini Size by Wuhan Pakcare Bio‐technology Co., Ltd. — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697358909HP100MD | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697358909HP100MD | Class I | Active |
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Manufacturer
- Manufacturer
- Wuhan Pakcare Bio‐technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000008960
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (2)
- EUDAMED e4b10eb7-52c3-409a-9992-5603c96d4d01 61 fields · synced Jun 18, 2026
- EUDAMED 3acb30a7-5328-4ea3-9c1d-6a37510dea08 61 fields · synced May 19, 2026