Identity
- Trade Name
- Back Gel Pack EUDAMED
- Device Name
- Hot and Cold Gel Packs (Medcosa & Magic Gel) EUDAMED
- Model / Reference
- 25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060824391017 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
Category: Hot/cold therapy pack, reusable
Back Gel Pack by Stretton Online 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 | 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 7ac3c4e6-0150-4f79-899f-0ef2e6ac92af 61 fields · synced Jun 19, 2026