Identity
- Trade Name
- EZ-Swivel EUDAMED
- Device Name
- Quick Coupler EUDAMED
- Model / Reference
- HP3018 EUDAMEDHP3040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00990010312357 EUDAMED
- Basic UDI-DI
- 99001030147492 EUDAMED
- Direct Marketing DI
- 00990010312357 EUDAMED
- EMDN Code
- Z12119099 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
EZ-Swivel by Beyes Dental Inc — 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 | 99001030147492 | Class I | Active |
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Manufacturer
- Manufacturer
- Beyes Dental Inc
- EUDAMED SRN
- CA-MF-000001491
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 0082d9b5-a255-4728-8bf1-8c8af8b60c77 61 fields · synced May 22, 2026