Identity
- Trade Name
- Getwell EUDAMED
- Device Name
- Aid Plaster EUDAMED
- Model / Reference
- GM835 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08681285119834 EUDAMED
- Basic UDI-DI
- 868128511G10034R EUDAMED
- EMDN Code
- M0599 MEDICAL PLASTERS - OTHER 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 | 868128511G10034R | Class I | Active |
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Manufacturer
- Manufacturer
- Honnes Sağlık ve Endüstriyel Ürünleri A.Ş
- EUDAMED SRN
- TR-MF-000017199
Sources (1)
- EUDAMED eb5d2174-5495-4e98-ac43-831ec0e71aca 61 fields · synced Oct 5, 2026