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Dermosil Cooling Gel
EUDAMEDClass I (EU MDR)
Ref 4218Model Class I Health Care
by Berner Oy
Identity
- Trade Name
- Dermosil Cooling Gel EUDAMED
- Model / Reference
- Class I Health Care EUDAMED4218 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06416952421802 EUDAMED
- Basic UDI-DI
- 641450LR01ET EUDAMED
- Direct Marketing DI
- 06416952421802 EUDAMED
- EMDN Code
- M9002 PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
Dermosil Cooling Gel by Berner Oy — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 641450LR01ET | Class I | Active |
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Manufacturer
- Manufacturer
- Berner Oy
- EUDAMED SRN
- FI-MF-000007402
Sources (1)
- EUDAMED b6c19d67-398c-4290-b22d-060aaffac037 61 fields · synced Jul 31, 2026