Identity
- Device Name
- MAXPERT EUDAMED
- Model / Reference
- MAXPERT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800012401695 EUDAMED
- Basic UDI-DI
- B-08800012401695 EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Maxpert by Shinhung Co., Ltd. — Class IIa — 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-08800012401695 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shinhung Co., Ltd.
- EUDAMED SRN
- KR-MF-000022813
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 88a734fe-c34f-4430-87b7-0a95eb2ff597 61 fields · synced Aug 2, 2026