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Cooling gel patch
EUDAMEDClass I (EU MDR)
Ref 1~50CM*1~50CMModel 1~50CM*1~50CM, Customized
Identity
- Trade Name
- Cooling gel patch EUDAMED
- Device Name
- Cooling gel patch EUDAMED
- Model / Reference
- 1~50CM*1~50CM, Customized EUDAMED1~50CM*1~50CM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978841800704 EUDAMED
- Basic UDI-DI
- 697884180Cgpatch01U7 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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 Yiwu City Ange Medical Instrument CO., LTD — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hot/cold therapy pack, reusable.
- Future Generation Medical — Global International L. L. C. · Class I
- Hot Cold Pack - Universal customized Cartoon pack Jurassic & Gabby's Dollhouse — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
- HOT/COLD THERAPY SLIPPER — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
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- HOT/COLD THERAPEUTIC PACK FOR KNEE — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
- hot cold pack — Anhui Kamt Ice Pack Co.,Ltd. · Class I
- ACCU-THERM — MEDLINE INDUSTRIES, INC. · Class I
- HotCold Pack reusable — Bevaplast B.V. · 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 | 697884180Cgpatch01U7 | Class I | Active |
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Manufacturer
- Manufacturer
- Yiwu City Ange Medical Instrument CO., LTD
- EUDAMED SRN
- CN-MF-000048646
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 8cba62d8-4ef8-4c59-ad66-dce56fdaa5ba 61 fields · synced Jun 19, 2026