HomeChinaShenzhen Witleaf Medical Electronics Co., Ltd

Shenzhen Witleaf Medical Electronics Co., Ltd

China · 深圳 · www.szwitleaf.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000040494Unified social credit code 914403000940768221

This company holds 5 NMPA certificates in China and has registrations in European Union, United States, South Korea, Australia — 4 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
5China registrations
Class II 5
as of 2026-09-04
EUEuropean UnionEUDAMED
149UDI-DI device records
Class IIa 11Class IIb 138
USUnited StatesFDA openFDA
4listed device types
Class I 1Class II 3Class III 0
plus 5 registration records and 2 510(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
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
2active ARTG entries
IIb 2
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 Union149 raw hits, 0 excluded, 149 confirmed
United States5 registration records, 2 510(k), 0 PMA
China5 certificates (Class III 0 / II 5 / I 0), as of 2026-09-04
Manufacturer names merged into this page: SHENZHEN WITLEAF MEDICAL ELECTRONICS CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000040494
EU authorised representative
Zug Medical Systems
Unified social credit code
914403000940768221
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
67
Annual revenue
RMB 30–50M
Website
www.szwitleaf.com
Product categories
医用电子康复 & 养老设备维修智慧健康

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
2014-03-27
Registered capital
CNY 5,000,000
Paid-in capital
CNY 740,000
Legal form
Limited liability company
Industry classification
Professional technical services
Last approval date
2023-06-17
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseInnovative 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

12022 · K213430
12023 · K213431

FDA listed device types

Oximeter, Wellness 1Oximeter, Infrared, Sporting, Aviation 1Oximeter 1Airway, Nasopharyngeal 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20252070585病人监护仪Class II
CN粤械注准20222070254病人监护仪Class II
CN粤械注准20222070092呼吸末二氧化碳监测仪Class II
CN粤械注准20182070519生命体征监护仪Class II
EU06970005396474Patient MonitorClass IIb
EU06970005396467Patient MonitorClass IIb
EU06970005396450Patient MonitorClass IIb
EU06970005396443Patient MonitorClass IIb
USK213431Handheld Pulse Oximeter2023-02-26
USK213430Fingertip Pulse Oximeter2022-12-30

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