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Cooling Gel Sheet
EUDAMEDClass I (EU MDR)
Ref 120mm*50mmModel 120mm*50mm
110mm*40mm
105mm*45mm
100mm*40mm
70mm*40mm
Ref N/A
Identity
- Device Name
- Cooling Gel Sheet EUDAMED
- Model / Reference
- 120mm*50mm 110mm*40mm 105mm*45mm 100mm*40mm 70mm*40mm EUDAMED120mm*50mm EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944270104331 EUDAMED06944270104379 EUDAMED06944270104348 EUDAMED06944270104355 EUDAMED
- Basic UDI-DI
- 69442701TTS01TR EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMEDNetherlands 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: Device sterilization/disinfection container, reusable
Cooling Gel Sheet by Jiangmen New Era External Use Drug Co., Ltd — Class I — 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69442701TTS01TR | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangmen New Era External Use Drug Co., Ltd
- EUDAMED SRN
- CN-MF-000036495
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED d0fa1e97-d2cd-42ea-b804-88760ec07ebc 61 fields · synced Jul 31, 2026
- EUDAMED 7b03fff5-c02c-4eb1-acb9-10bab1085f1b-1 61 fields · synced Jul 9, 2026
- EUDAMED aa9c1770-ed21-4fd0-83ea-39095884d677-1 61 fields · synced Jul 11, 2026
- EUDAMED e82a0dcc-1ca4-4b79-9e0c-01cd73aef109-1 61 fields · synced Jul 31, 2026