Medical-device manufacturing licence
粤食药监械生产许20193331号
Class II, category 19 (medical rehabilitation devices) · valid to 2029-01-30
Issued by Guangdong Medical Products Administration
Quality & compliance
Credentials you can verify.
Manufacturing in Zhongshan since 2016, trading entity in Guangzhou since 2014 — factory and export operation under one ownership. Every certificate number below can be checked with the issuing authority; copies and per-model test reports are sent directly on request.
Medical-device online sales filing
粤穗食药监械经营备20212362号
Class II distribution filing, Guangzhou Daerdo Technology Co., Ltd.
Filed with Guangzhou Administration for Market Regulation · verifiable online
DAERDO® registered trademark
Reg. No. 50759267, Class 10
Hearing aids and related medical devices · valid 2021–2031
Registered with CNIPA (China National Intellectual Property Administration)
Foreign trade operator registration
No. 04865079
Customs registration code 4401968CBK · export tax-rebate filing in place
Registered export trading entity
Manufacturing facility
International certifications held by our production base.
Devices are built at Zhongshan Great-Ears Electronic Technology Co., Ltd., our manufacturing base under the same ownership. The certificates below are held by that facility and can be checked at source.
FDA establishment registration
Reg. No. 3013596029
Device listing QUF — hearing aid, air-conduction, over-the-counter (21 CFR 874.3300). Prescription listing ESD also on file.
Verifiable in the FDA establishment registration database · US agent: Registrar Corp
ISO 13485 quality management
Certificate No. 130802
Scope: design, production and sale of hearing aids (ear-carried and endoauricular types).
Certified by NQA · UKAS / IAF accredited
FCC verification of conformity
No. CTB161104001E-ZS
Tested to CFR Title 47, FCC Part 15 for radio-frequency emissions.
Issued by Shenzhen CTB Testing Technology Co., Ltd.
RoHS certificate of conformity
No. CTB161104006C-ZS
EU Directive 2011/65/EU on restriction of hazardous substances · EPA / EN 1122 / IEC 62321 test series.
Issued by Shenzhen CTB Testing Technology Co., Ltd.
Click any certificate to view the full document
FDA registration and listing means the facility and its device categories are on file with the US FDA. It is not an FDA approval or endorsement — no hearing aid carries one. Certificate copies and per-model test reports are sent directly on request.
Market-specific documents (labels, IFUs, registrations) are handled per model, destination country and revision during inquiry review.
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