Tech Love
by Guangzhou New design Biotechnology Co., Ltd. China EUDAMED
Ref X1, X2Model TJ-608
EMDN Y061299
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697570507TJ-608H7 | Date14 Sep 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Bunion Corrector
- Model / Reference
- TJ-608, X1, X2
- Primary DI / UDI-DI
- 06975705070013, 06975705070020, 06975705070112
- Basic UDI-DI
- 697570507TJ-608H7
- 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
Other devices from Guangzhou New design Biotechnology Co., Ltd.
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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 (3)
- EUDAMED 9c2ea978-44da-4d51-b422-377377f17b0d
- EUDAMED 06975705070020|697570507TJ-608H7
- EUDAMED 06975705070112|697570507TJ-608H7