HomeChinaNINGBO HANYUE MEDICAL TECHNOLOGY CO.,LTD

NINGBO HANYUE MEDICAL TECHNOLOGY CO.,LTD

China · Ningbo Zhejiang · www.hanyuemedi.com
✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000035941Unified social credit code 91330282MA2J4QBT8K

This company holds 7 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Israel — 5 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
7China registrations
Class I 7
as of 2026-09-04
EUEuropean UnionEUDAMED
192UDI-DI device records
Class I 26Class IIa 166
USUnited StatesFDA openFDA
27listed device types
Class I 19Class II 7Class III 0unclassified 1
plus 27 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
5registered device records
Class I 1Class IIa 4
BRBrazilANVISA
1registered devices
Class 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
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 Union192 raw hits, 0 excluded, 192 confirmed
United States27 registration records, 0 510(k), 0 PMA
China7 certificates (Class III 0 / II 0 / I 7), as of 2026-09-04
United Kingdom5 confirmed, 0 excluded
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: NINGBO HANYUE MEDICAL TECHNOLOGY CO.,LTD · NINGBO HANYUE MEDICAL TECHNOLOGY CO.,LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000035941
EU authorised representative
MedPath GmbH
UK responsible person
MedPath Limited
Unified social credit code
91330282MA2J4QBT8K
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Ningbo Zhejiang
Social-insurance enrolees
26
Annual revenue
RMB 50–100M
Website
www.hanyuemedi.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentAnaesthesia, intensive care & life-support systems

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
2021-02-02
Registered capital
CNY 6,315,800
Paid-in capital
CNY 500,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2026-07-23
Recognitions
Micro and small enterpriseNational High-Tech 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 listed device types

showing 8 of 27
First Aid Kit With Drug 1Mouthpiece, Breathing 1Mask, Oxygen, Non-Rebreathing 1First Aid Kit Without Drug 1Airway, Nasopharyngeal 1Mask, Gas, Anesthetic 1Dressing, Wound, Occlusive 1Exerciser, Non-Measuring 1

Registration details (sample)

MarketIdentifierNameClass / date
CN浙甬械备20260054一次性肺功能仪用过滤嘴Class I
CN浙甬械备20230246呼吸训练器Class I
CN浙甬械备20230236医用透气胶带Class I
CN浙甬械备20230224鼻氧管Class I
EU06975834950705PVC Manual ResuscitatorClass IIa
EU06975834950682PVC Manual ResuscitatorClass IIa
EU06975834955892CPAP Mask SClass IIa
EU06975834955885CPAP Mask MClass IIa
UK57813CPAP MASKClass IIa
UK57813CPAP MASKClass IIa
UK47368Choking Rescue DeviceClass I
BR82696719004Máscara CPAPClass II

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