Identity
- Device Name
- Dental air-turbine handpieces EUDAMED
- Model / Reference
- KT-600NL EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809394971444 EUDAMED
- Basic UDI-DI
- B-08809394971444 EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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: Dental delivery system
Dental air-turbine handpieces by Saeyang Co., Ltd. — Class IIa — 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-08809394971444 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Saeyang Co., Ltd.
- EUDAMED SRN
- KR-MF-000034170
- Authorised Representative
- Marathon Italia S.R.L. IT-AR-000027858
Sources (1)
- EUDAMED c3c2b12e-4212-43ed-a405-5e3f3eb27f91 61 fields · synced Jul 24, 2026