Trial Frame
by Danyang Xingda Optical Instrument Co., Ltd. China EUDAMED
Ref UTF-T4880Model UTF-T4880PRO,UTF4880,UTF5470, STF5270,STF-T5072,UTF-T4880
EMDN Q0299
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697504250XD02HL | Date15 May 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- UTF-T4880, UTF-T4880PRO, UTF4880, UTF5470, STF5270, STF-T5072
- Primary DI / UDI-DI
- 06975042508880, 06975042500174
- Basic UDI-DI
- 697504250XD02HL
- EMDN Code
- Q0299, Q02100299
- Device Class
- Class I
- Market of Registration
- ItalyBulgaria
Manufacturer details
- EUDAMED SRN
- CN-MF-000017346
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Sterile: No
- Implantable: 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 (2)
- EUDAMED fc5c7406-1b5f-484a-a2d9-837f52799c7e
- EUDAMED 06975042500174|697504250XD02HL