Identity
- Trade Name
- Sümer EUDAMED
- Device Name
- SM-TKI Tek Kapılı Isıtma Kabini 350 L EUDAMED
- Model / Reference
- SM-TKI 350 L EUDAMED--- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698918587052 EUDAMED
- Basic UDI-DI
- B-08698918587052 EUDAMED
- EMDN Code
- Z12030305 INFUSION HEATERS 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 by Sümer Uluslararasi Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ — Class I — 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-08698918587052 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000022362
Sources (1)
- EUDAMED 68d93ca3-946a-408c-8ec2-d6b40b1e991b 61 fields · synced Oct 6, 2026