Identity
- Trade Name
- Vestibulum Cheek Retractor 16.5cm EUDAMED
- Device Name
- Vestibulum Cheek Retractor 16.5cm EUDAMED
- Model / Reference
- 3321 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964004296215 EUDAMED
- Basic UDI-DI
- 89640042963321Y7 EUDAMED
- EMDN Code
- L150201 DENTAL RETRACTORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Vestibulum Cheek Retractor 16.5cm by Mediface Instruments — 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 | 89640042963321Y7 | Class I | Active |
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Manufacturer
- Manufacturer
- Mediface Instruments
- EUDAMED SRN
- PK-MF-000044762
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED e82348f7-608c-442f-8db1-2045adfa0503 61 fields · synced Jun 19, 2026