Identity
- Trade Name
- Getwell EUDAMED
- Device Name
- COOLING FEVER PATCH EUDAMED
- Model / Reference
- G1011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08681285109200 EUDAMED
- Basic UDI-DI
- 868128510G10114B EUDAMED
- EMDN Code
- M04040502 HYDROGEL DRESSINGS, COMBINED WITH OTHER SUBSTANCES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Getwell by Honnes Sağlık ve Endüstriyel Ürünleri A.Ş — 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 | 868128510G10114B | Class I | Active |
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Manufacturer
- Manufacturer
- Honnes Sağlık ve Endüstriyel Ürünleri A.Ş
- EUDAMED SRN
- TR-MF-000017199
Sources (1)
- EUDAMED 07b64237-3e9e-4b2b-95ff-dde1bf24dc9a 61 fields · synced Oct 5, 2026