HomeChinaShenzhen Elite Medical Technology Co.,Ltd

Shenzhen Elite Medical Technology Co.,Ltd

China · 深圳 · www.ailite.com
✓ Record-verifiedregistrations found in 2 marketsUnified social credit code 91440300745154258L

This company holds 32 NMPA certificates in China and has registrations in United States — 1 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
32China registrations
Class I 6Class II 25Class III 1
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
49listed device types
Class I 26Class II 22Class III 0unclassified 1
plus 169 registration records and 6 510(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
pendingnot queried
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 Union194 raw hits, 194 excluded, 0 confirmed
United States169 registration records, 6 510(k), 0 PMA, 21 excluded
China32 certificates (Class III 1 / II 25 / I 6), as of 2026-09-04
United Kingdom0 confirmed, 12 excluded
Brazil0 confirmed, 2 excluded
Saudi Arabia0 confirmed, 5 excluded
Manufacturer names merged into this page: Elite Medical, LLC
Same-named companies — This database also contains companies with near-identical names: ELITE MEDICAL ( NANJING ) CO., LTD. Company name alone cannot separate their registrations, so the figures below may include either.

Regulatory identity

Unified social credit code
91440300745154258L
Exhibition record
Rehab & Elderly Care Expo (Spring 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
136
Annual revenue
RMB 100–500M
Website
www.ailite.com
Product categories
康复 & 养老物理治疗器械医用康复器械患者承载器械

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
2002-11-22
Registered capital
CNY 5,000,000
Paid-in capital
CNY 5,000,000
Legal form
Limited liability company
Industry classification
Pharmaceutical manufacturing
Last approval date
2025-05-22
Recognitions
Micro and small enterpriseNational High-Tech 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 510(k) clearances by year

51990 · K900733
12011 · K101482

FDA listed device types

showing 8 of 49
Template 1Rasp 1Probe 1Clamp 1Impactor 1Guide, Surgical, Instrument 1Screwdriver 1Reamer 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20253092732气囊式体外反搏设备Class III
CN粤械注准20262070124无创血流动力学检测仪Class II
CN粤械注准20262070121运动血压监测仪Class II
CN粤械注准20252211719心肺功能数据处理软件Class II
USK101482EM-90002011-03-31
USK900733PROTEIN TEST FOR URINE AND CSF1990-07-10
USK901001URIC ACID TEST KIT1990-05-23

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