SperSort Sperm Sorting Chip (IPG02)
Ipreg Incorporation · Obstetrics/Gynecology
Open FDA's page for this record- Third party flag
- N
- City
- New Taipei City
- Advisory committee description
- Obstetrics/Gynecology
- Address 1
- 4f-3., # 77, Sec. 1, Xintai 5th Rd., Xizhi Dist.,
- Statement or summary
- Summary
- Product code
- MQK
- Zip code
- 221
- Applicant
- Ipreg Incorporation
- Decision date
- 2025-02-20
- Decision code
- SESE
- Country code
- TW
- Device name
- SperSort Sperm Sorting Chip (IPG02)
- Advisory committee
- OB
- Contact
- Ching-Wen Chang
- K number
- K241626
- Date received
- 2024-06-06
- Review advisory committee
- OB
- Postal code
- 221
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Labware, Assisted Reproduction
- Medical specialty description
- Obstetrics/Gynecology
- Regulation number
- 884.6160
- Device class
- 2
- Registration number
- 3007738736, 3006405073, 3017896194, 8043396, 9611680, 3006795808, 8043792, 3017247483, 3003244268, 3016090200, 9617744, 3012416874, 3014527900, 1820334, 3012853704, 3014053517, 1221433, 1058584, 1054657, 3014295858, 3005987240, 3015550658, 3008876063, 3016838734, 3004048494, 3015140190, 1423662, 3043639843, 3002807090, 1222779, 3010781586, 3015522136, 3002807408, 3016927399, 3009107689, 3036495174, 3003995932, 2953359, 2245304, 3031594904 +15 more
- FEI number
- 3007738736, 1000110807, 1000219637, 3006405073, 3017896194, 3006795808, 3002807969, 3017247483, 3003244268, 3016090200, 3012416874, 3014527900, 1820334, 3012853704, 3014053517, 3006279007, 3005987240, 3014295858, 3004848623, 1221433, 3002808269, 3015550658, 3008876063, 3000215273, 3016838734, 3004048494, 3015140190, 3043639843, 3010781586, 3015522136, 1000120774, 3002807408, 3016927399, 3009107689, 3036495174, 3003995932, 2245304, 3031594904, 3009747883, 1220477 +15 more