HomeChinaNingbo Hecai Medical Equipments Co., Ltd.

Ningbo Hecai Medical Equipments Co., Ltd.

China · 宁波
✓ Record-verifiedregistrations found in 7 marketsEU SRN CN-MF-000036553Unified social credit code 9133022674495347X0

This company holds 10 NMPA certificates in China and has registrations in European Union, United States, Saudi Arabia, Taiwan, Australia, Russia — 6 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
10China registrations
Class I 8Class II 2
as of 2026-09-04
EUEuropean UnionEUDAMED
19UDI-DI device records
Class I 19
USUnited StatesFDA openFDA
8listed device types
Class I 7Class II 1Class III 0
plus 8 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
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
3valid device licences
Class I 3
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
Class I 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
4active registrations
Class 1 2Class 2a 2
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 Union19 raw hits, 0 excluded, 19 confirmed
United States8 registration records, 0 510(k), 0 PMA
China10 certificates (Class III 0 / II 2 / I 8), as of 2026-09-04
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: NINGBO HECAI MEDICAL EQUIPMENT CO.,LTD. · NINGBO HECAI MEDICAL EQUIPMENT CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000036553
EU authorised representative
SUNGO Europe B.V.
Unified social credit code
9133022674495347X0
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
104
Annual revenue
RMB 100–500M
Product categories
应急救援患者承载器械手术室及急救

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
2002-11-28
Registered capital
USD 13,000,000
Paid-in capital
USD 13,000,000
Legal form
Limited liability company (wholly owned by a HK/Macao/Taiwan corporation)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2025-09-24
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI SMEGazelle enterpriseInnovative 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 listed device types

Bed, Ac-Powered Adjustable Hospital 1Stretcher, Hand-Carried 1Exerciser, Non-Measuring 1Cabinet, Table And Tray, Anesthesia 1Table And Attachments, Operating-Room 1Chair And Table, Medical 1Device, Transfer, Patient, Manual 1Bed, Manual 1

Registration details (sample)

MarketIdentifierNameClass / date
CN浙械注准20232151346电动病床Class II
CN浙械注准20232150064医用电动转移车Class II
CN浙甬械备20240158诊查床Class I
CN浙甬械备20240105骨科牵引床Class I
EU06976591030198Class I
EU06976591030181Class I
EU06976591030174Class I
EU06976591030150Class I
SAME0000008109SFDAA00003Manual Transfer Stretcher

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