AOLIKE - Zhongshan Aolike Medical Equipment Technology Co., Ltd. Request Quote

AOLIKE buyer guide

CE, UKCA, FDA Registration and ISO Certificates: What Medical Equipment Buyers Should Verify

A practical explanation of the difference between company quality systems, product documentation and FDA registration or listing for medical equipment due diligence.

Company systems and product registrations

Management-system certificates help buyers evaluate the manufacturer, while product registrations and product documents apply only to the stated models, configurations, intended uses and markets. They must not be read as blanket approval of every AOLIKE product.

ISO 13485:2016 — certificate CN17/42102

SGS United Kingdom Ltd certifies AOLIKE’s medical-device quality management system for the scope stated on the certificate. SGS verification status: Revised. Valid through October 27, 2026.

View the ISO 13485 certificate PDF · Verify the certificate with SGS

ISO 9001, ISO 14001 and ISO 45001 — company systems

The supplied certificates identify Zhongshan Aolike Medical Equipment Technology Co., Ltd. and show a period from August 17, 2026 to August 16, 2029, subject to the validity and surveillance conditions stated in each document. Certificate numbers: ISO 9001 120426Q00275R010; ISO 14001 120426E00147R010; ISO 45001 120426S00135R010.

View ISO 9001 · View ISO 14001 · View ISO 45001

China manufacturing licence and product registrations

AOLIKE holds China medical device manufacturing licence No. 粤食药监械生产许20060374号 for the period December 20, 2024 to December 19, 2029. The stated scope includes Class II patient-support devices and Class II medical rehabilitation devices. A manufacturing licence does not replace the product registration or destination-market documents required for a specific model.

View the China manufacturing licence

FDA establishment registration and device listing

The FY2026 summary records establishment registration No. 3010411316 and Owner/Operator No. 10044148. FDA establishment registration and device listing do not mean FDA approval, clearance, authorization or certification.

View the company-prepared summary · Search the official FDA database

Official REHACARE 2026 exhibitor profile

The REHACARE Düsseldorf exhibitor profile identifies Zhongshan Aolike Medical Equipment Technology Co., Ltd. as a REHACARE 2026 exhibitor in Hall 6, Stand H56, from September 23–26, 2026.

View the REHACARE exhibitor profile

What buyers should confirm

  • The exact model and configuration stated in the quotation.
  • The scope, issuing body and validity date of each document.
  • The regulatory requirements of the destination country and intended use.
  • The model-specific specification, manual, packing data and applicable documents.
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