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Shenzhen Root Innovation Technology Co., , Ltd.

China · Shenzhen

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Australia, Hong Kong — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

7listed device types

Class I 4Class II 3Class III 0

plus 19 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

9 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

IIa 3

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States19 registration records, 13 510(k), 0 PMA, 2 excluded

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: SHENZHEN ROOT INNOVATION TECHNOLOGY CO., LTD. · SHENZHEN ROOT INNOVATION TECHNOLOGY CO.,LTD.

FDA 510(k) clearances by year

32024

22025

82026 · K254254

FDA listed device types

Stocking, Medical Support (For General Medical Purposes) 1Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure 1Binder, Abdominal 1Components, Exercise 1Pump, Breast, Powered 1Pump, Portable, Aspiration (Manual Or Powered) 1Breast Pump Kit 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254254	Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)	2026-06-18
US	K260538	Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )	2026-06-17
US	K253629	Momcozy Nasal Aspirator (BN007)	2026-05-26
BR	82195309052	Bomba Tira-Leite Portátil Momcozy	Class II
BR	82195309053	Bomba Tira-Leite Portátil Momcozy	Class II
BR	82195309055	Bomba Tira-Leite Portátil Momcozy	Class II

Shenzhen Root Innovation Technology Co., , Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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