Identity
- Trade Name
- KS Scan body (Intraoral) EUDAMED
- Device Name
- Impression Tool System EUDAMED
- Model / Reference
- KSNSBSTH EUDAMEDKSNSBLTH EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800209360897 EUDAMED08800209360859 EUDAMED
- Basic UDI-DI
- 88000406CLASSIBUSANHY EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
KS Scan body (Intraoral) by Osstem Implant Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000406CLASSIBUSANHY | Class I | Active |
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Manufacturer
- Manufacturer
- OSSTEM IMPLANT Co., Ltd.
- EUDAMED SRN
- KR-MF-000020006
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED d0f72c07-5832-4146-9733-85ce8494ad2e 61 fields · synced Jun 20, 2026
- EUDAMED 9539a912-d0de-4a8c-95db-be68b98e2f59 61 fields · synced May 19, 2026