HomeChinaSuZhou Juneland Medical Co.,Ltd.

SuZhou Juneland Medical Co.,Ltd.

China · 苏州 · www.juneld.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000034149

This company holds 55 NMPA certificates in China and has registrations in European Union, United States, Australia, Israel — 4 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
55China registrations
Class I 28Class II 27
as of 2026-09-04
EUEuropean UnionEUDAMED
46UDI-DI device records
Class I 31Class IIa 15
USUnited StatesFDA openFDA
3listed device types
Class I 2Class II 1Class III 0
plus 3 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
6active ARTG entries
IIa 6
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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 Union46 raw hits, 0 excluded, 46 confirmed
United States3 registration records, 0 510(k), 0 PMA
China55 certificates (Class III 0 / II 27 / I 28), as of 2026-09-04
Manufacturer names merged into this page: SUZHOU JUNELAND MEDICAL CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000034149
EU authorised representative
MedPath GmbH
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
66
Website
www.juneld.com
Product categories
手术器械呼吸、麻醉和急救器械注输、护理和防护器械

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
2017-03-31
Registered capital
CNY 5,000,000
Legal form
Limited liability company (wholly owned by a natural person)
Industry classification
Wholesale trade
Last approval date
2022-07-02
Recognitions
Micro and small enterpriseNational High-Tech EnterprisePrivate 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 listed device types

Kit, Surgical Instrument, Disposable 1Catheter, Irrigation 1Catheter And Tip, Suction 1

Registration details (sample)

MarketIdentifierNameClass / date
CN苏械注准20262170845一次性使用无菌吸唾管Class II
CN苏械注准20252140089一次性使用无菌给药器Class II
CN苏械注准20242140486一次性使用引流套件Class II
CN苏械注准20242140417一次性使用手术单Class II
EU06976143667209Universal Irrigation Set -1or2 WaysClass IIa
EU06976143661351Irrigation set for motorClass IIa
EU06976143667124Suction Dralnage TubeClass I
EU06976143667131Suction Dralnage TubeClass I

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