← Back to catalogue
Dental contra angle handpieces
EUDAMEDClass IIa (EU MDR)
Ref -Model SP-CEModel Ki-AG20Model SP-RA16
Identity
- Device Name
- Dental contra angle handpieces EUDAMED
- Model / Reference
- SP-CE EUDAMED- EUDAMEDKi-AG20 EUDAMEDSP-RA16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809394971154 EUDAMED08809394970874 EUDAMED08809394971055 EUDAMED
- Basic UDI-DI
- B-08809394971154 EUDAMEDB-08809394970874 EUDAMEDB-08809394971055 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 contra angle handpieces by Saeyang Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental delivery system.
- Dental Unit — Lifedent (Zhuhai) Co., Ltd. · Class IIa
- V8 TOUCH — VITALI S.R.L. · Class IIa
- Forest — Ls Enterprises, Inc. · Class I
- Forest — Ls Enterprises, Inc. · Class I
- TY-830 — Foshan Toye Dental Equipment Co., Ltd · Class I
- Forest — Ls Enterprises, Inc. · Class I
- A5 SINGLE CART — CEFLA s.c. · Class IIa
- Forest — Ls Enterprises, Inc. · Class I
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-08809394971154 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Saeyang Co., Ltd.
- EUDAMED SRN
- KR-MF-000034170
- Authorised Representative
- Marathon Italia S.R.L. IT-AR-000027858
Sources (3)
- EUDAMED 93dac351-67bc-4b27-9b06-f9a883f99bab 61 fields · synced Jul 31, 2026
- EUDAMED 14a9c083-0b3b-4be7-b63d-dfca1577453a 61 fields · synced May 17, 2026
- EUDAMED f76dfa64-671b-407b-9e71-67f125792467 61 fields · synced May 18, 2026