Identity
- Trade Name
- Sümer EUDAMED
- Device Name
- ELENA 1 Tek Kapılı Yıkama ve Dezenfeksiyon Cihazı 230 L EUDAMED
- Model / Reference
- ELENA-1 230 L EUDAMED--- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683962868868 EUDAMED
- Basic UDI-DI
- B-08683962868868 EUDAMED
- EMDN Code
- Z12011301 CLEANING AND DISINFECTION EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye 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
Sümer by Sümer Uluslararasi Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ — Class IIb — 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-08683962868868 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000022362
Sources (1)
- EUDAMED 79522af8-0fd8-4073-80fa-d14d5b5c2b3d 61 fields · synced Oct 6, 2026