Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)
Dongguan Zsr Biomedical Technology Company Limited · Gastroenterology, Urology
Open FDA's page for this record- Third party flag
- N
- City
- Dongguan
- Advisory committee description
- Gastroenterology, Urology
- Address 1
- Unit 448, Qingfeng Rd., Taihu Village
- Address 2
- Sanzhong Village Committee, Qingxi Town
- Statement or summary
- Summary
- Product code
- FGB
- Zip code
- 523651
- Applicant
- Dongguan Zsr Biomedical Technology Company Limited
- Decision date
- 2025-02-11
- Decision code
- SESE
- Country code
- CN
- Device name
- Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)
- Advisory committee
- GU
- Contact
- Wen Sharon
- K number
- K243155
- Date received
- 2024-09-30
- Review advisory committee
- GU
- Postal code
- 523651
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Ureteroscope And Accessories, Flexible/Rigid
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.1500
- Device class
- 2
- Registration number
- 3025349506, 3013247477, 8010047, 3042940358, 3029981244, 8010298, 1000484830, 3012322232, 3019807891, 2531475, 9616693, 3010707607, 9610773, 1418479, 3033010858, 3022106566, 3003782610, 3008439484, 3035484431, 3004111573, 3002808148, 9611612, 2936485, 9614434, 3011986317, 9610877, 3028058843, 3024021261, 3008998256, 1221826, 3020369549, 3011050570, 3003542872, 9610617, 1000121056, 3014683069, 3013992977, 1820334, 3010202439, 3037966040 +80 more
- FEI number
- 3003448211, 3025349506, 3013247477, 3006149253, 3002806565, 3042940358, 3029981244, 3002808273, 1000484830, 3012322232, 3019807891, 3002807847, 3010707607, 3008185830, 1418479, 3033010858, 3022106566, 3003782610, 3008439484, 3035484431, 3004111573, 3002808148, 3000206435, 3002808268, 2936485, 4430, 3011986317, 1000138054, 3028058843, 3024021261, 3002806359, 3008998256, 1221826, 3020369549, 3011050570, 3003542872, 1000121056, 3014683069, 3013992977, 1820334 +80 more