HomeChinaZhejiang Hisern Medical Device Co.,Ltd.

Zhejiang Hisern Medical Device Co.,Ltd.

China · 绍兴 · www.hisern.com
✓ Record-verifiedregistrations found in 1 marketsUnified social credit code 91330600724537794K

This company holds 72 NMPA certificates in China.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
72China registrations
Class II 41Class III 11
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 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.

China72 certificates (Class III 11 / II 41 / I 0), as of 2026-09-04

Regulatory identity

Unified social credit code
91330600724537794K
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
377
Annual revenue
RMB 100–500M
Website
www.hisern.com
Product categories
医用电子手术室及急救手术器械呼吸、麻醉和急救器械

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
2000-10-10
Registered capital
CNY 75,294,118
Paid-in capital
CNY 75,294,118
Legal form
Joint-stock limited company (listed)
Industry classification
Other manufacturing
Last approval date
2026-05-21
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseNational SRDI "Little Giant"SRDI SMERecognised enterprise technology centreHidden championAbove-designated-size industrial enterprise
Listing
Listed on the A-share marketDelisted from the NEEQListed on a regional equity market

Business registration data from Tianyancha, as of 2026-09-03. 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.

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20243141393便携式电动输液泵Class III
CN国械注准20243080739一次性使用麻醉穿刺套件Class III
CN国械注准20233070806麻醉深度监护仪Class III
CN国械注准20233030756一次性使用中心静脉导管及套件Class III

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