Tenicore
by Guangzhou New design Biotechnology Co., Ltd. China EUDAMED
Ref X3Model TE-X3
EMDN Y061299
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697570507TE-X3M5 | Date26 Sep 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Bunion Corrector
- Model / Reference
- TE-X3, X3
- Primary DI / UDI-DI
- 06975705070136
- Basic UDI-DI
- 697570507TE-X3M5
- EMDN Code
- Y061299 Lower extremity orthoses - other
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000028399
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
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Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 723f30b0-8475-4ac2-a172-13da2c8cac82