HomeChinaHarbin Howell Medical Apparatus and Instruments Co., Ltd

Harbin Howell Medical Apparatus and Instruments Co., Ltd

China · 哈尔滨 · www.hxeyl.com
✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000025141Unified social credit code 912301106968245097

This company holds 16 NMPA certificates in China and has registrations in European Union, United States, Brazil, Australia, Russia — 5 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
16China registrations
Class I 12Class II 4
as of 2026-09-04
EUEuropean UnionEUDAMED
64UDI-DI device records
Class I 64
USUnited StatesFDA openFDA
4listed device types
Class I 3Class II 1Class III 0
plus 4 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
1registered devices
Class I 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
1active ARTG entries
Class I 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
1active registrations
Class 1 1
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 Union64 raw hits, 0 excluded, 64 confirmed
United States4 registration records, 0 510(k), 0 PMA, 4 excluded
China16 certificates (Class III 0 / II 4 / I 12), as of 2026-09-04
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: HARBIN HOWELL MEDICAL APPARATUS AND INSTRUMENTS CO.,LTD. · HARBIN HOWELL MEDICAL APPARATUSAND INSTRUMENTS CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000025141
EU authorised representative
Caretechion GmbH
Unified social credit code
912301106968245097
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
55
Annual revenue
under RMB 5M
Website
www.hxeyl.com
Product categories
患者承载器械手术器械

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
2010-01-06
Registered capital
CNY 10,000,000
Paid-in capital
CNY 2,999,985
Legal form
Limited liability company
Industry classification
Special-purpose equipment manufacturing
Last approval date
2025-08-19
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMESRDI SME
Listing
Listed on a regional equity market

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

Apparatus, Traction, Non-Powered 1Support, Patient Position 1Table, Operating-Room, Electrical 1Lamp, Operating-Room 1

Registration details (sample)

MarketIdentifierNameClass / date
CN黑械注准20222150059电动手术台Class II
CN黑械注准20192180035电动液压妇科手术台Class II
CN黑械注准20192150036电动液压外科手术台Class II
CN黑械注准20182010040手术无影灯Class II
EU06974445421154HOWELLClass I
EU06974445420140HOWELLClass I
EU06974445420133HOWELLClass I
EU06974445420126HOWELLClass I
BR82753370001ESTRIBOS HOWELLClass I

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