OHA (Orthèse Herbst Amoric)
by Fulcrum EUDAMED
Active
Ref 1.71, 1.2, 1.81, 1.11, 2.2, 3.9, 2.1
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number3770024630008UZ | Date6 Feb 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- Withdrawn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
- Trade Name
- OHA Orthèse Herbst Amoric C
- Device Name
- OHA (Orthèse Herbst Amoric)
- Model / Reference
- 1.71, 1.2, 1.81, 1.11, 2.2, 3.9, 2.1
- Primary DI / UDI-DI
- 03770024630114, 03770024630169, 03770024630091, 03770024630008, 03770024630060, 03770024630015, 03770024630077
- Basic UDI-DI
- 3770024630008UZ
- EMDN Code
- Q010499 Orthodontic devices - other
- Device Class
- Class I
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000015624
Other devices from Fulcrum
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