Direct answer
Yes. Zhongshan Aolike Medical Equipment Technology Co., Ltd. is recorded in EUDAMED as a manufacturer under SRN CN-MF-000011467 and has an EU authorised representative. The SRN identifies the economic operator; it is not product approval or an MDR certificate. Buyers must separately verify the exact model, configuration, intended use and documents applicable to the destination market.
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.
EUDAMED registration and EU authorised representative
Zhongshan Aolike Medical Equipment Technology Co., Ltd. is recorded as a manufacturer in the EUDAMED economic operator register. The record identifies SUNGO Europe B.V. as the authorised representative and shows a mandate valid through July 26, 2031.
| Manufacturer | Zhongshan Aolike Medical Equipment Technology Co., Ltd. |
|---|---|
| EUDAMED role | Manufacturer |
| Manufacturer SRN | CN-MF-000011467 |
| EU authorised representative | SUNGO Europe B.V., Netherlands |
| Representative SRN | NL-AR-000000247 |
| Mandate validity | July 28, 2021–July 26, 2031 |
Search the SRN in EUDAMED · Read the official SRN explanation
Evidence boundary: an SRN identifies an economic operator. It does not by itself show that a model is approved, certified or registered as a device. The applicable EU declaration of conformity, technical documentation, labelling, UDI and device registration must be confirmed for the supplied model and configuration.
ISO 13485:2016 and EN ISO 13485:2016 — NQA certificates
The NQA certificates supplied by AOLIKE identify Zhongshan Aolike Medical Equipment Technology Co., Ltd.: ISO 13485:2016, no. 135845, and EN ISO 13485:2016, no. 135846. Both show an issue date of October 12, 2026 and a valid-until date of October 11, 2029, subject to maintaining the system and the surveillance assessments stated in the documents.
View both NQA certificates in the PDF
The scope covers design, manufacture and sales, within licensed qualifications, of the equipment listed in the certificates. Review the PDF for the exact scope. These system certificates do not replace the conformity documents for a specific model or destination market.
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
Authorised-representative mandate category scope
The signed mandate annex reviewed September 24, 2026 lists 11 Class I device groups and specific models: electric wheelchairs, manual wheelchairs, walkers, walking sticks and walking aids, manual hospital beds, commode wheelchairs and commode chairs, electric hospital beds, shower chairs, emergency trolleys, instrumental trolleys and medical stretchers. Inclusion of a category does not automatically confirm every model in the current catalogue; request the current document set for the exact model.
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.