HomeChinaYangzhou Medline Industry Co., Ltd.

Yangzhou Medline Industry Co., Ltd.

China · Yangzhou Jiangsu · www.chinamedline.com
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, United Kingdom, Brazil, Taiwan, Singapore, South Korea, Australia, Hong Kong — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
11listed device types
Class I 6Class II 5Class III 0
plus 11 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
11registered device records
Class I 2Class IIa 9
BRBrazilANVISA
142registered devices
Class I 44Class II 98
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
9valid device licences
Class I 1Class II 8
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Manufacturing 1
AUAustraliaTGA ARTG
17active ARTG entries
IIa 15Class Is (sterile) 2
HKHong KongMDACS
1valid listings
Class II 1
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 Union18,489 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified
United States11 registration records, 2 510(k), 0 PMA, 32 excluded
United Kingdom11 confirmed, 2 excluded
Brazil142 confirmed, 9 excluded
Saudi Arabia0 confirmed, 4 excluded
Canada0 confirmed, 3 excluded
Manufacturer names merged into this page: YANGZHOU MEDLINE INDUSTRY CO., LTD. · YANGZHOU MEDLINE INDUSTRY CO.LTD · YANGZHOU MEDLINE INDUSTRY CO., LTD · Yangzhou Medline Industry CO., Ltd · Yangzou Medline Industry Co., Ltd

Regulatory identity

UK responsible person
lotus global co ltd

Company information

Country
China
City
Yangzhou Jiangsu
Website
www.chinamedline.com
Product categories
Integrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

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.

FDA 510(k) clearances by year

12017 · K170651
12023 · K230080

FDA listed device types

showing 8 of 11
Syringe, Irrigating (Non Dental) 1Container, Specimen, Sterile 1Brush, Scrub, Operating-Room 1Container, Liquid Medication, Graduated 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Needle, Aspiration And Injection, Disposable 1Syringe, Piston 1Respirator, Surgical 1

Registration details (sample)

MarketIdentifierNameClass / date
UK35210Dispensing NeedlesClass IIa
UK35210BLUNT NEEDLESClass I
UK47017Disposable SyringesClass IIa
USK230080Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood2023-07-07
USK170651Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle2017-08-02
BR10150470496Agulha Hipodérmica estéril de uso único WiltexClass II
BR10150470497Seringa hipodérmica estéril de uso único para uso manual com dispositiClass I
BR10160610101AGULHA DE COLETA MÚLTIPLA COM DISPOSITIVO DE SEGURANÇAClass II

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