TheraTogs
by Theratogs Inc EUDAMED
Active
Ref GLE201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8100494GLEBE | Date19 Nov 2021 | 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- Withdrawn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
- Theratogs Lower Extremity Systems
- Model / Reference
- GLE201
- Primary DI / UDI-DI
- 00810049430269
- Basic UDI-DI
- 8100494GLEBE
- Direct Marketing DI
- 00810049430269
- EMDN Code
- Y061218 Hip-knee-ankle-foot orthoses
- Device Class
- Class I
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000001407
- Authorised representative
- MedEnvoy Global BV NL-AR-000024028
Other devices from Theratogs 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