HomeChinaShantou Wealy Medical Instrument Co., Ltd.

Shantou Wealy Medical Instrument Co., Ltd.

China · Shantou · www.wealy.com
✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000020619

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Australia, Israel — 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
43UDI-DI device records
Class I 9Class IIa 34
USUnited StatesFDA openFDA
10listed device types
Class I 6Class II 4Class III 0
plus 14 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
6registered device records
Class I 3Class IIa 3
BRBrazilANVISA
2registered devices
Class II 2
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
2 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
IIa 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 Union43 raw hits, 0 excluded, 43 confirmed
United States14 registration records, 6 510(k), 0 PMA
United Kingdom6 confirmed, 0 excluded
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD. · SHANTOU WEALY MEDICAL INSTRUMENT CO.,LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000020619
EU authorised representative
Lotus NL B.V.
UK responsible person
lotus global co ltd

Company information

Country
China
City
Shantou
Website
www.wealy.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

12012 · K113587
12014 · K141640
22021 · K203613
22022 · K222452

FDA listed device types

showing 8 of 10
Syringe, Irrigating (Non Dental) 1Cabinet, Table And Tray, Anesthesia 1Container, Liquid Medication, Graduated 1Syringe, Ent 1Instrument, Manual, Surgical, General Use 1Gauze / Sponge,Nonresorbable For External Use 1Syringe, Antistick 1Enteral Syringes With Enteral Specific Connectors 1

Registration details (sample)

MarketIdentifierNameClass / date
EU06971603580067Disposable Insulin SyringeClass IIa
EU06971603580050Disposable Insulin SyringeClass IIa
EU16971603580002Disposable Tuberculin SyringeClass IIa
EU06971603584058Disposable Hypodermic NeedleClass IIa
UK62001Reusable Enteral Feeding SyringesClass I
UK59040Disposable Enteral Feeding SyringesClass I
UK34973Disposable Insulin Safety SyringesClass IIa
USK222452Disposable Automatically Retractable Safety Syringes (with detachable needle)2022-11-23
USK210216Disposable Automatically Retractable Insulin Safety Syringe2022-03-04
USK203613ENFit Reusable Enteral Syringe2021-08-27
BR80842600001SERINGA DE SEGURANÇA DESCARTÁVEL AUTOMÁTICA RETRÁTIL (COM AGULHA AFIXAClass II
BR80451960057NPH MEDICAL SERINGA DESCARTÁVEL COM SISTEMA DE SEGURANÇA COM AGULHAClass II

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