Identity
- Trade Name
- Sümer EUDAMED
- Device Name
- WD-2 Çift Kapılı Yıkama ve Dezenfeksiyon Cihazı 250 L EUDAMED
- Model / Reference
- WD-2 250 L EUDAMED--- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698918589346 EUDAMED
- Basic UDI-DI
- B-08698918589346 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
Similar devices
Also classified as Surgical utensil washer/disinfector.
- Steelco — STEELCO SPA · Class II
- Antiseptic Applicator — Poly Medicure Limited · Class I
- WD1260-SC-060 — Smeg S.p.A. · Class IIb
- Getinge Aquadis Index — GETINGE DISINFECTION AB · Class IIa
- Getinge ED-FLOW AER RANGE — GETINGE DISINFECTION AB · Class IIb
- CS 750 — Belimed Infection Control AG · Class IIa
- WD7015TM — Smeg S.p.A. · Class IIb
- AF2.60XMEG — AT-OS SRL · Class IIa
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-08698918589346 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- TR-MF-000022362
Sources (1)
- EUDAMED 53fbd774-afd1-400a-976c-6bf36045eb59 61 fields · synced Jul 18, 2026