Hinge Axis Recorder
by Advanced Dental Designs, Inc. EUDAMED
Active
Ref HA770010Model HA750000
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number860003403HA750000JC | Date28 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- Hinge Axis Recorder
- Model / Reference
- HA750000, HA770010
- Primary DI / UDI-DI
- 00850090837907
- Basic UDI-DI
- 860003403HA750000JC
- EMDN Code
- Q010499 Orthodontic devices - other
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- US-MF-000057788
- Authorised representative
- MedEnvoy Global BV NL-AR-000024028
From the manufacturer
Manufacturer's product page: Hinge Axis Recorder & Accessories
Other devices from Advanced Dental Designs, Inc.
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: 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