Identity
- Trade Name
- Alpheta EUDAMED
- Device Name
- Steril Wound Dressing EUDAMEDSterile Wound Dressing EUDAMED
- Model / Reference
- A6130P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08681285102492 EUDAMED
- Basic UDI-DI
- B-08681285102492 EUDAMED868128510A6107PXQ EUDAMED
- EMDN Code
- M04010199 ADHESIVE DRESSINGS, WITH ABSORBENT PAD - OTHER EUDAMEDM04010102 POLYURETHANE (OR OTHER MATERIAL) ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
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
Alpheta by Honnes Sağlık ve Endüstriyel Ürünleri A.Ş — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08681285102492 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-08681285102492 | Class I | Active |
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Manufacturer
- Manufacturer
- Honnes Sağlık ve Endüstriyel Ürünleri A.Ş
- EUDAMED SRN
- TR-MF-000017199
Sources (2)
- EUDAMED d27ef69c-76eb-4d77-9481-f74dfb7aa194 61 fields · synced Oct 8, 2026
- EUDAMED 2ce127c7-57ae-476b-b9bc-d9252c3f2e32 61 fields · synced Oct 8, 2026