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Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.

China · Shanghai

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

1listed device types

Class I 0Class II 1Class III 0

plus 4 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 2Class II 1

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

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

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 States4 registration records, 4 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: FIMILLA (SHANGHAI) MATERNITY & BABY ARTICLES CO., LTD · FIMILLA (SHANGHAI) MATERNITY & BABY ARTICLES CO., LTD.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254125	Electric Breast Pump (HL-3058 II Pro)	2026-05-13
US	K252630	Electric Breast Pump (HL-3060, F5113)	2025-10-27
US	K252629	Electric Breast Pump (HL-3058, F5112)	2025-10-27
BR	80275319003	BOMBA TIRA-LEITE MATERNO MANUAL	Class I
BR	80275319004	Bomba Tira-Leite Materno Elétrica	Class II
BR	80275310092	Bomba Tira Leite Automática G-Tech	Class I

Fimilla (Shanghai) Maternity & Baby Articles 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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