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Cooling gel patch
EUDAMEDClass I (EU MDR)
Ref MDN 1214 General non-active non-implantable devices used in health care and other nonactive non-implantable devicesModel Type A/Type B/Type C/Type D
Identity
- Trade Name
- Cooling gel patch EUDAMED
- Device Name
- Cooling gel patch EUDAMED
- Model / Reference
- Type A/Type B/Type C/Type D EUDAMEDMDN 1214 General non-active non-implantable devices used in health care and other nonactive non-implantable devices EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945296010903 EUDAMED
- Basic UDI-DI
- 69452960Coglpatch001V4 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
Cooling gel patch by Wuhan Huawei Technology Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hot/cold therapy pack, reusable.
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- hot cold pack — Anhui Kamt Ice Pack Co.,Ltd. · Class I
- HotCold Pack reusable — Bevaplast B.V. · Class I
- reusable cold hot gel pack for Ankle — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69452960Coglpatch001V4 | Class I | Active |
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Manufacturer
- Manufacturer
- Wuhan Huawei Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000014668
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED ca108c44-2110-41ef-8932-cfe8a5d432d9 61 fields · synced Aug 2, 2026