HomeChinaGuangdong Horigen Mother & Baby Products Co.,Ltd.

Guangdong Horigen Mother & Baby Products Co.,Ltd.

China · 汕头 · www.horigen.cn
✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000021982Unified social credit code 9144051372706956XE

This company holds 5 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, South Korea, Australia, Israel, Russia — 9 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
5China registrations
Class I 3Class II 2
as of 2026-09-04
EUEuropean UnionEUDAMED
11UDI-DI device records
Class I 1Class IIa 10
USUnited StatesFDA openFDA
3listed device types
Class I 2Class II 1Class III 0
plus 8 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
3registered device records
Class I 1Class IIa 2
BRBrazilANVISA
6registered devices
Class I 2Class II 4
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered 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
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
2active ARTG entries
IIa 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
6registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 1
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.

European Union11 raw hits, 0 excluded, 11 confirmed
United States8 registration records, 6 510(k), 0 PMA
China5 certificates (Class III 0 / II 2 / I 3), as of 2026-09-04
United Kingdom3 confirmed, 0 excluded
Brazil6 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: Guangdong Horigen Mother & Baby Products Co., Ltd. · GUANGDONG HORIGEN MOTHER & BABY PRODUCTS CO., LTD · GUANGDONG HORIGEN MOTHER & BABY PRODUCTS CO., LTD. · Guangdong HORIGEN Mother & Baby Products Co.,Ltd

Regulatory identity

EU manufacturer SRN
CN-MF-000021982
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
9144051372706956XE
Exhibition record
Rehab & Elderly Care Expo (Spring 2026, Shanghai)

Company information

Country
China
Social-insurance enrolees
264
Annual revenue
RMB 100–500M
Website
www.horigen.cn
Product categories
家用器械

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Registration status
Active
Incorporated
1997-04-21
Registered capital
CNY 50,000,000
Paid-in capital
CNY 50,000,000
Legal form
Joint-stock limited company (unlisted, natural-person invested or controlled)
Industry classification
Rubber and plastic products
Last approval date
2023-06-28
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI SMEAbove-designated-size industrial enterprise
Listing
Delisted from the NEEQ

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

12016 · K162747
12019 · K182413
12020 · K193449
22021 · K201152
12022 · K212564

FDA listed device types

Pump, Breast, Powered 1Irrigator, Powered Nasal 1Pump, Breast, Non-Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20242140923电动洗鼻器Class II
CN粤械注准20182140584负压可调式平衡吸乳器Class II
CN粤汕械备20250007鼻部冲洗器Class I
CN粤汕械备20250001鼻部冲洗器Class I
EU06940657923267NimoClass IIa
EU06940657902149HORIGENClass IIa
EU06940657902088HORIGENClass IIa
EU06940657902071HORIGENClass IIa
UK38478ELECTRIC BREAST PUMPClass IIa
UK38478ELECTRIC BREAST PUMPClass IIa
UK38477MANUAL BREAST PUMPClass I
USK212564Electric Breast Pump2022-05-06
USK201152Electric Breast Pump2021-05-04
USK201974Single-use medical face mask2021-03-07
BR80998260002Bomba Tira-Leite 2 em 1 MAM - Extração DuplaClass I
BR80998260003Bomba Tira-Leite 2 em 1 MAM – Extração UnitáriaClass II
BR83370229001PUREFLOW BOMBA TIRA LEITE ELETRICA E PORTATILClass II
SAME0000000385SFDAA00032VITAL BABY Nurture Flexcone Manual Breast Pump

Similar companies

Acoresmed Co., Ltd.
China · markets 1
Aimagine Care Technology Co., Ltd.
China · markets 2
Allmed Medical Products Co. Ltd.
China · markets 12
ALTON(shanghai)medical Instruments Co.,Ltd
China · markets 12
Ambulanc (Shenzhen) Tech. Co. Ltd.
China · markets 10
Andon Health Co., Ltd.
China · markets 10
Is this your company? Claim the page, add information or report a data error.Claim / report an error →