HomeChinaXinwell Medical Technology Co., Ltd Co., Ltd.

Xinwell Medical Technology Co., Ltd Co., Ltd.

China · Cixi City Ningbo Zhejiang · www.xinwell.com
✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000001084Unified social credit code 91330200MA293LCD5X

This company holds 36 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, South Korea, Australia, Hong Kong, Israel — 9 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
36China registrations
Class II 33Class III 3
as of 2026-09-04
EUEuropean UnionEUDAMED
92UDI-DI device records
Class I 1Class IIa 91
USUnited StatesFDA openFDA
12listed device types
Class I 6Class II 6Class III 0
plus 13 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
15registered device records
Class I 1Class IIa 13Class IIb 1
BRBrazilANVISA
12registered devices
Class II 12
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
8 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
2active ARTG entries
IIa 1IIb 1
HKHong KongMDACS
2valid listings
Class II 2
ILIsraelAMAR
3registrations
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 Union92 raw hits, 0 excluded, 92 confirmed
United States13 registration records, 2 510(k), 0 PMA
China36 certificates (Class III 3 / II 33 / I 0), as of 2026-09-04
United Kingdom15 confirmed, 0 excluded
Brazil12 confirmed, 0 excluded
Manufacturer names merged into this page: NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD. · NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000001084
EU authorised representative
Lotus NL B.V.
UK responsible person
lotus global co ltd
Unified social credit code
91330200MA293LCD5X
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Cixi City Ningbo Zhejiang
Social-insurance enrolees
355
Annual revenue
RMB 30–50M
Website
www.xinwell.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.

Business registration

Registration status
Active
Incorporated
2017-08-18
Registered capital
CNY 119,900,000
Paid-in capital
CNY 119,900,000
Legal form
Joint-stock limited company (unlisted)
Industry classification
Rubber and plastic products
Last approval date
2025-08-01
Recognitions
National High-Tech EnterpriseTechnology-based SMESRDI SMEInnovative 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

22024 · K232969

FDA listed device types

showing 8 of 12
Endoscopic Injection Needle, Gastroenterology-Urology 1Cable, Transducer And Electrode, Patient, (Including Connector) 1Bottle, Collection, Vacuum 1Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 1Blood Pressure Cuff 1Hemostatic Metal Clip For The Gi Tract 1Forceps, Biopsy, Non-Electric 1Laryngoscope, Rigid 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20243011570一次性使用电圈套器Class III
CN国械注准20233010148一次性使用乳头括约肌切开刀Class III
CN国械注准20223020987一次性闭合夹Class III
CN浙械注准20262060366电子膀胱肾盂内窥镜Class II
EU06971944912763Laryngoscope BladesClass IIa
EU06971944912770Laryngoscope BladesClass IIa
EU06971944912787Laryngoscope BladesClass IIa
EU06971944912732Video LaryngoscopesClass IIa
UK10749Closed Sunction CathetersClass IIa
UK46232Disposable Anesthetic MasksClass IIa
UK64327Disposable Core Biopsy InstrumentsClass IIa
USK232969Disposable Hemostatic Clips2024-06-07
USK232200Disposable Injection Needles2024-04-12
BR82195309030Instrumentos de biópsia descartáveisClass II
BR82195309029Máscaras anestésicas descartáveisClass II
BR82195309036Filtros Descartáveis de Trocador de Calor e UmidadeClass II

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