Identity
- Trade Name
- PERIOSTOME BUSAR,HOLLOW EUDAMED
- Device Name
- ELEVATOR LUXATOR 2MM FIG.1 EUDAMED
- Model / Reference
- ELEVETOR EUDAMEDD-169-361 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961104043824 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
Periostome Busar, Hollow 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 8735e625-e2b3-454f-9dcd-749da048de12 61 fields · synced Jun 20, 2026