HomeChinaJiangsu Hope Biomedical Science&Technology Co.,Ltd

Jiangsu Hope Biomedical Science&Technology Co.,Ltd

China · 扬州 · www.hope-bio.com
✓ Record-verifiedregistrations found in 6 marketsUnified social credit code 91321012558070884M

This company holds 18 NMPA certificates in China and has registrations in United States, United Kingdom, Brazil, Saudi Arabia, Russia — 5 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
18China registrations
Class I 4Class II 12Class III 2
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
2listed device types
Class I 1Class II 1Class III 0
plus 3 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
1registered device records
Class IIb 1
BRBrazilANVISA
3registered devices
Class I 2Class II 1
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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
1active registrations
Class 2b 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 Union29,261 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified
United States3 registration records, 2 510(k), 0 PMA, 10 excluded
China18 certificates (Class III 2 / II 12 / I 4), as of 2026-09-04
United Kingdom1 confirmed, 18 excluded
Brazil3 confirmed, 2 excluded
Saudi Arabia1 confirmed, 3 excluded
Manufacturer names merged into this page: Jiangsu Hope Biomedical Science&Technology Co.,Ltd. · JIANGSU HOPE MEDICAL INSTRUMENT CO.,LTD. · JIANGSU HOPE BIOMEDICAL SCIENCE & TECHNOLOGY CO. LTD. · High Hope International Group Jiangsu Medicines and Health Products Import and Export Corp

Regulatory identity

UK responsible person
Wellkang Ltd
Unified social credit code
91321012558070884M
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
99
Annual revenue
RMB 30–50M
Website
www.hope-bio.com
Product categories
手术器械注输、护理和防护器械医用成像器械

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
2010-07-07
Registered capital
CNY 10,000,000
Paid-in capital
CNY 10,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2024-07-08
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseInnovative SME

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

12023 · K231615
12024 · K232703

FDA listed device types

Instrument, Manual, Surgical, General Use 1Electrosurgical, Cutting & Coagulation & Accessories 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20253030621一次性使用颅内牵开固定导管Class III
CN国械注准20183141542负压引流护创系统Class III
CN苏械注准20262010590冲吸式消融电极Class II
CN苏械注准20242010148多功能手术解剖器Class II
UK56296Disposable Nonstick Bipolar Control Electrocoagulation TweezerClass IIb
USK232703Disposable Bipolar Forceps2024-03-06
USK231615Disposable Endoscopic Bipolar2023-12-05
BR80532650001Conjunto de Fixação para Fragmentos Pequenos (Simples)Class I
BR80532650002Conjunto de Fixação para Fragmentos Grandes (Simples)Class I
BR80857109017DISPOSABLE IRRIGATION & SUCTION DEVICEClass II
SAME0000007085SFDAA00001BEST PE Disposable Gloves

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