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Nüve
EUDAMEDClass IIb (EU MDR)
Ref Z10.FN 400Model FN 400
by Nüve Sanayi̇ Malzemeleri̇ İmalat Ve Ti̇caret Anoni̇m Şi̇rketi̇
Identity
- Trade Name
- NÜVE EUDAMED
- Device Name
- FN 400 STERİLİZATÖR ( Sterilizer ) EUDAMED
- Model / Reference
- FN 400 EUDAMEDZ10.FN 400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698863111029 EUDAMED
- Basic UDI-DI
- B-08698863111029 EUDAMED
- EMDN Code
- Z12011307 DRY AIR STERILISERS 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
Nüve by Nüve Sanayi̇ Malzemeleri̇ İmalat 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-08698863111029 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000018127
Sources (1)
- EUDAMED 5b3e2fe8-8f99-42da-9600-780c667e3946 61 fields · synced Oct 6, 2026