Identity
- Trade Name
- Glove Gel Pack EUDAMED
- Device Name
- Hot and Cold Gel Packs (Medcosa & Magic Gel) EUDAMED
- Model / Reference
- 45 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060824391123 EUDAMED
- Basic UDI-DI
- 506082439hcgpacksQ2 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Estonia 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
Glove Gel Pack by Stretton Online Ltd — 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 | 506082439hcgpacksQ2 | Class I | Active |
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Manufacturer
- Manufacturer
- Stretton Online Ltd
- EUDAMED SRN
- GB-MF-000017858
- Authorised Representative
- Stretton Europe OÜ EE-AR-000017337
Sources (1)
- EUDAMED 414622cf-de51-4d61-95d1-2501dd58cb46 61 fields · synced Jun 17, 2026