Identity
- Trade Name
- Sümer EUDAMED
- Device Name
- SM-YKD 1 Tek Kapılı Yıkama Dezenfeksiyon Cihazı 250 L EUDAMED
- Model / Reference
- SM-YKD 1 250 L EUDAMED--- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698918581050 EUDAMED
- Basic UDI-DI
- B-08698918581050 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
Category: Surgical utensil washer/disinfector
Sümer by Sümer Uluslararasi Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-08698918581050 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000022362
Sources (1)
- EUDAMED edea1a91-8052-4b63-9497-eeb740240f0a 61 fields · synced Oct 6, 2026