HomeChinaNingbo HLS Medical Products CO., LTD

Ningbo HLS Medical Products CO., LTD

China · Cixi Ningbo Zhejiang · www.nbhls.net
✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000026849Unified social credit code 91330282662052635X

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

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
9China registrations
Class I 6Class II 3
as of 2026-09-04
EUEuropean UnionEUDAMED
168UDI-DI device records
Class I 168
USUnited StatesFDA openFDA
7listed device types
Class I 3Class II 4Class III 0
plus 7 registration records and 1 510(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
2GMP quality-system certificates
Import 1Manufacturing 1
AUAustraliaTGA ARTG
1active ARTG entries
Class I 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 Union179 raw hits, 11 excluded, 168 confirmed
United States7 registration records, 1 510(k), 0 PMA
China9 certificates (Class III 0 / II 3 / I 6), as of 2026-09-04
United Kingdom0 confirmed, 1 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: NINGBO HLS MEDICAL PRODUCTS CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000026849
EU authorised representative
MedPath GmbH
Unified social credit code
91330282662052635X
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Cixi Ningbo Zhejiang
Social-insurance enrolees
26
Annual revenue
RMB 30–50M
Website
www.nbhls.net
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instruments

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
2007-05-11
Registered capital
CNY 25,000,000
Paid-in capital
CNY 10,500,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Wholesale trade
Last approval date
2025-11-11
Recognitions
National High-Tech EnterpriseSRDI SMEAbove-designated-size industrial enterprise

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

12015 · K141057

FDA listed device types

Applicator, Absorbent Tipped, Sterile 1Container, Specimen Mailer And Storage, Sterile 1Accessory, Surgical Apparel 1Chest Drainage Kit 1Spatula, Cervical, Cytological 1Bottle, Collection, Vacuum 1Apparatus, Suction, Operating-Room, Wall Vacuum Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
CN浙械注准20242221607一次性使用采样盒Class II
CN浙械注准20212220054一次性使用采样拭子Class II
CN浙械注准20172181163一次性使用宫颈采样拭子Class II
CN浙甬械备20250018负压引流器Class I
EU06949717003741Disposable Sampling SwabClass I
EU06949717003628Disposable Sampling SwabClass I
EU06949717003604Disposable Sampling SwabClass I
EU06949717003536Disposable Sampling SwabClass I
USK141057DISPOSABLE CERVICAL BRUSH2015-05-14

Similar companies

ALTON(shanghai)medical Instruments Co.,Ltd
China · markets 12
Anhui Tiankang Medical Technology Co., Ltd
China · markets 10
Auckland Medical Polymer (Tianjin) Co., Ltd.
China · markets 9
Baisheng Medical Co., Ltd.
China · markets 9
Beijing Datsing Bio-Tech Co., Ltd.
China · markets 2
Beijing Eternity Electronic Technology Co.,Ltd
China · markets 2
Is this your company? Claim the page, add information or report a data error.Claim / report an error →