SHENZHEN ROOT INNOVATION TECHNOLOGY CO., LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30213761023021376102SHENZHEN ROOT INNOVATION TECHNOLOGY CO., LTD.1N2026-01-01Room 3301, Aerospace Innovation Building, No. 7013 Liuxian Avenu Nanshan District, Shenzhen Guangdong CN 518071

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3000981603709739K260538Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )HGX2026-06-17
3000981789106609K260134Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)BTA2026-05-15
3000981410833698K254258Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D)HGX2026-04-08
3000981614508307K253946Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C)HGX2026-04-07
3000981916961059K253934Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)HGX2026-03-09
3000981006572827K253629Momcozy Nasal Aspirator (BN007)BTA2026-05-26
3000981512408720K253283Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)HGX2025-10-29
3000981932596835K251450Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009)BTA2025-06-06
3000981963665616K251394Momcozy Wearable Breast Pump (BP223)HGX2025-09-08
3000981257294298K243629Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcozy Wearable Breast Pump (BP334); Momcozy Wearable Breast Pump (BP430)HGX2024-12-20
3000981426846323K241680Momcozy Wearable Breast Pump (BP311)HGX2024-12-20
3000981918495132K233880Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141)HGX2024-03-06
3000981005005961K230776Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)HGX2023-06-09
3000981575859599K223693Electric breast pump (model: M5)HGX2023-03-09
3000981752116493K220309Wearable Breast Pump (Model S10)HGX2022-06-27
3000981368634153
3000981536019006
3000981559908241
3000981746901474
3000981970599378
3000982047204848

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HGX122026-06-17
BTA32026-05-26

PMN#

GUDID#

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