Zogear
by ZOGEAR Medical Co., Ltd. EUDAMED
Active
Ref AS001-1L、AS001-2、AS001-3、AS007Model AS00-1L、AS001-2、AS001-3、AS007
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697484312AS001EG | Date4 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Air water syringe tips
- Model / Reference
- AS00-1L、AS001-2、AS001-3、AS007, AS001-1L、AS001-2、AS001-3、AS007
- Primary DI / UDI-DI
- 06974843127955
- Basic UDI-DI
- 697484312AS001EG
- EMDN Code
- Z12119099 Various dental stomatology instruments - other
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000012353
- Authorised representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Other devices from ZOGEAR Medical Co., Ltd.
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No