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Dermogesic non-flammable Cold Spray
EUDAMEDClass IIa (EU MDR)
Ref DERMOGESIC100MLRef DERMOGESIC100M
by Vitame Ltd
Identity
- Trade Name
- Dermogesic non-flammable Cold Spray EUDAMEDDermogesic Non-flammable Cold Spray (Direct Stream) EUDAMED
- Device Name
- Dermogesic non-flammable Cold Spray EUDAMEDCryogesic Fine Spray EUDAMED
- Model / Reference
- DERMOGESIC100ML EUDAMEDDERMOGESIC100M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060411670044 EUDAMED
- Basic UDI-DI
- B-05060411670044 EUDAMED506041167VAPOCOOLANTWE EUDAMED
- Direct Marketing DI
- 05060411670044 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland EUDAMEDIreland 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
Dermogesic non-flammable Cold Spray by Vitame Ltd — Class IIa — MDR, MDD — 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
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-05060411670044 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-05060411670044 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Vitame Ltd
- EUDAMED SRN
- GB-MF-000015647
- Authorised Representative
- Elara Pharmaservices Europe Ltd IE-AR-000011852
Sources (2)
- EUDAMED c3e4c9e3-1245-42ab-acf6-005411686f78 61 fields · synced Jun 19, 2026
- EUDAMED 45b6fb3d-71aa-427e-b9d5-eb8f0547e480 61 fields · synced May 18, 2026