Identity
- Trade Name
- Alpheta EUDAMED
- Device Name
- Steril Wound Dressing EUDAMED
- Model / Reference
- A6125P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08681285102478 EUDAMED
- Basic UDI-DI
- B-08681285102478 EUDAMED
- EMDN Code
- M04010199 ADHESIVE DRESSINGS, WITH ABSORBENT PAD - 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Alpheta by Honnes Sağlık ve Endüstriyel Ürünleri A.Ş — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08681285102478 | Class I | Active |
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Manufacturer
- Manufacturer
- Honnes Sağlık ve Endüstriyel Ürünleri A.Ş
- EUDAMED SRN
- TR-MF-000017199
Sources (1)
- EUDAMED 7b410f4c-a4a7-4e51-b386-ced985bb38ea 61 fields · synced Oct 5, 2026