Identity
- Trade Name
- ELEVATOR BEIN 3MM FIG.4 EUDAMED
- Device Name
- ELEVATOR LUXATOR 2MM FIG.1 EUDAMED
- Model / Reference
- ELEVETOR EUDAMEDD-028-137 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961104043695 EUDAMED
- Basic UDI-DI
- 896110404ELEVATORCLASSIJQ EUDAMED
- EMDN Code
- L150799 ORTHODONTIC INSTRUMENTS, REUSABLE - OTHER 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
Elevator Bein 3mm Fig.4 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 | 896110404ELEVATORCLASSIJQ | 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 b13c81bb-7de7-49d5-b8ad-e374d9e4d563 61 fields · synced Jul 22, 2026