Identity
- Trade Name
- WHITE BURNISHER,SOLID FIG.26/27S EUDAMED
- Device Name
- FILLING INSTRUMENTS EUDAMED
- Model / Reference
- D-104-584 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961104040588 EUDAMED
- Basic UDI-DI
- 896110404FIL/INSTCLASSIRS EUDAMED
- EMDN Code
- L159014 ODONTOSTOMATOLOGY BURNISHERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
White Burnisher, Solid Fig.26/27s by Mark One Surgical — 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 | 896110404FIL/INSTCLASSIRS | Class I | Active |
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Manufacturer
- Manufacturer
- Mark One Surgical
- EUDAMED SRN
- PK-MF-000031202
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED 053fd05a-c090-461e-9920-9ebfa47d0008 61 fields · synced Jul 20, 2026