HomeChinaKimlead Hygiene Products (Hebei)Co.,Ltd.

Kimlead Hygiene Products (Hebei)Co.,Ltd.

China · Xingtai City Hebei province · www.kimlead.com
✓ Record-verifiedregistrations found in 3 marketsEU SRN CN-MF-000025989

This company holds 2 NMPA certificates in China and has registrations in European Union, United States — 2 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
2China registrations
Class I 2
as of 2026-09-04
EUEuropean UnionEUDAMED
80UDI-DI device records
Class I 80
USUnited StatesFDA openFDA
5listed device types
Class I 5Class II 0Class III 0
plus 5 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
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.

European Union80 raw hits, 0 excluded, 80 confirmed
United States5 registration records, 0 510(k), 0 PMA
China2 certificates (Class III 0 / II 0 / I 2), as of 2026-09-04
Manufacturer names merged into this page: KIMLEAD HYGIENE PRODUCTS (HEBEI) CO.,LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000025989
EU authorised representative
SUNGO Europe B.V.
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Xingtai City Hebei province
Social-insurance enrolees
41
Website
www.kimlead.com
Product categories
Integrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

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
2020-12-29
Registered capital
CNY 10,000,000
Paid-in capital
CNY 5,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Paper and paper products
Last approval date
2020-12-29

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 listed device types

Pad, Menstrual, Unscented 1Garment, Protective, For Incontinence 1Cover, Mattress (Medical Purposes) 1Fiber, Medical, Absorbent 1Apron, Protective 1

Registration details (sample)

MarketIdentifierNameClass / date
CN冀邢械备20240008医用隔离垫Class I
CN冀邢械备20210017医用护理垫Class I
EU06975359621555Class I
EU06975359621562Class I
EU06975359621258Class I
EU06975359620367Class I

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