Identity
- Trade Name
- Sümer EUDAMED
- Device Name
- ELENA WIDE Genel Cerrahi Ameliyat Masası EUDAMED
- Model / Reference
- ELENA WIDE EUDAMED--- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698918581395 EUDAMED
- Basic UDI-DI
- B-08698918581395 EUDAMED
- EMDN Code
- Z12011202 OPERATING TABLES EUDAMED
Classification
- Device Class
- Class I 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 is a medical device designed for general cataract surgery, offering unparalleled precision and ease of use. With its advanced technology and minimal invasiveness, Sümer has revolutionized the field of ophthalmology, providing patients with faster recovery times and improved outcomes.
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-08698918581395 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000022362
Sources (1)
- EUDAMED 6013ed78-1c2e-41f1-8b01-952124615a01 61 fields · synced Oct 9, 2026