HomeChinaSuzhou KYUAN Medical Apparatus Co.,Ltd

Suzhou KYUAN Medical Apparatus Co.,Ltd

China · 苏州 · www.medi-kyuan.com
✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000021229Unified social credit code 913205077357089153

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

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
7China registrations
Class I 3Class II 4
as of 2026-09-04
EUEuropean UnionEUDAMED
84UDI-DI device records
Class IIa 84
USUnited StatesFDA openFDA
4listed device types
Class I 1Class II 3Class III 0
plus 5 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
4registered device records
Class IIa 4
BRBrazilANVISA
69registered devices
Class I 5Class II 64
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
1valid device licences
Class I 1
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.

European Union84 raw hits, 0 excluded, 84 confirmed
United States5 registration records, 2 510(k), 0 PMA
China7 certificates (Class III 0 / II 4 / I 3), as of 2026-09-04
United Kingdom4 confirmed, 0 excluded
Brazil69 confirmed, 0 excluded
Manufacturer names merged into this page: SUZHOU KYUAN MEDICAL APPARATUS CO., LTD. · SUZHOU KYUAN MEDICAL APPARATUS

Regulatory identity

EU manufacturer SRN
CN-MF-000021229
EU authorised representative
Llins Service & Consulting GmbH
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
913205077357089153
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
35
Annual revenue
RMB 100–500M
Website
www.medi-kyuan.com
Product categories
手术器械临床检验器械及试剂

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
2002-03-11
Registered capital
CNY 3,000,000
Paid-in capital
CNY 3,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Metal products
Last approval date
2026-06-03
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMEPrivate technology enterprise

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.

FDA 510(k) clearances by year

22022 · K221778

FDA listed device types

Multiple Use Blood Lancet For Single Patient Use Only 1Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature 1Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 1Blade, Scalpel 1

Registration details (sample)

MarketIdentifierNameClass / date
CN苏械注准20212220845一次性使用末梢采血针Class II
CN苏械注准20192020831一次性使用无菌手术刀片Class II
CN苏械注准20172022208无菌塑柄手术刀Class II
CN苏械注准20162160057一次性使用无菌眼科手术刀Class II
EU16971517662290Disposable Safety LancetsClass IIa
EU16971517661804Disposable Safety LancetsClass IIa
EU16971517661798Disposable Safety LancetsClass IIa
EU16971517664003Disposable Safety LancetsClass IIa
UK61579Disposable Blood LancetsClass IIa
UK61578Disposable Safety LancetsClass IIa
UK37445Sterile Surgical BladesClass IIa
USK221778Disposable Safety Lancets2022-10-03
USK220387Disposable Blood Lancets2022-08-17
BR80495510180MEDIX BRASIL Conector valvulado sistema fechadoClass I
BR10330669168Bisturi de Segurança Descartável DescarpackClass II
BR10310039003Lancetas de SegurançasClass II

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