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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Amoy Diagnostics Co., LTD. — Manufacturer in China

EUDAMED update: Mar 6, 2026

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Amoy Diagnostics Co., LTD.

China

All roles followed

Views by role

Sources: EUDAMED

Legal information of AmoyDx

Legal name: Amoy Diagnostics Co., LTD.
EU VAT number: Not applicable
Trade register: 9135020066474298XL
SRN (displayed role): CN-MF-000021843
EUDAMED status: Active· registered in 2022
Registered office: Dingshan Road, Haicang District, No.39 361027 Xiamen, China

Contact details for AmoyDx

Phone: +86 592 6806835
Email: intra@amoydx.com
Website: http://www.amoydx.com
Address: NO.39, DINGSHAN ROAD, HAICANG DISTRICT 361027 XIAMEN CHINA

Data export

Export the 48 devices of AmoyDx

Get the catalogue in Excel or CSV format — trade name, product reference, UDI and EMDN codes, legislation, quantity, last update, and more. The exact row count and price are confirmed before you pay.

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SRNCN-MF-000021843

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Medical device manufacturers in EUDAMED

Competent authority for AmoyDx

Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten
BelgiumContact the authority →

Market presence of AmoyDx

Devices placed in 4 countries

XI39
Netherlands7
Germany2
Belgium1

Risk categories of AmoyDx

Related documents of AmoyDx

Quality management system

Certificate V13 073028 0010Rev. Rev. 00

Issued

Manufacturer

Amoy Diagnostics Co., LTD.

Notified body

TÜV SÜD Product Service GmbH

0123

Version

1

Valid from

9/11/2026

Valid until

9/10/2031

Technical documentation

Certificate V76 073028 0011Rev. Rev. 00

Issued

Manufacturer

Amoy Diagnostics Co., LTD.

Notified body

TÜV SÜD Product Service GmbH

0123

Version

1

Valid from

9/11/2026

Valid until

9/10/2031

Executives & regulatory representatives of AmoyDx

2 contacts identified

PRRC
RUAN Li
Hidden

Cartography of AmoyDx

Authorised representativeNotified bodiesPeople

— 2 certificates — AmoyDx
— represents — AmoyDx
— AmoyDx

View profile →

TÜV SÜD Product Service GmbH

48Total Devices

48Basic UDI-DIs

2Certificates2 valid · 0 expiring < 12 months

4CountriesEU/EEA placements

Certificates of AmoyDx

Catalog of AmoyDx

48 devices · 48 families

Filter

AmoyDx® FFPE DNA/RNA Kit36 tests/kit1 version
AmoyDx® Tissue DNA Kit36 tests/kit1 version
AmoyDx® Tissue RNA Kit36 tests/kit1 version
AmoyDx® Blood/Bone Marrow DNA Kit36 tests/kit1 version
AmoyDx® FFPE RNA Kit36 tests/kit1 version
AmoyDx® Circulating DNA Kit24 tests/kit1 version
AmoyDx® FFPE DNA Kit36 tests/kit1 version
ANDAS SoftwareANDAS-EN1 version
AmoyDx® BRCA Pro Panel 24 tests/kit1 version
AmoyDx® HANDLE Classic NGS Panel24 tests/kit1 version
AmoyDx® HRD Focus Panel20 tests/kit1 version
AmoyDx® Pan Lung Cancer PCR Panel8 tests/kit1 version
AmoyDx® Pan Lung Cancer PCR Panel8 tests/kit1 version
AmoyDx® HRD Complete Panel20 tests/kit1 version
Super-ARMS® EGFR Mutation Detection Kit12 tests/kit1 version
AmoyDx® ROS1 Gene Fusions Detection Kit12 tests/kit1 version
AmoyDx® ROS1 Gene Fusions Detection Kit12 tests/kit1 version
AmoyDx® ROS1 Gene Fusions Detection Kit12 tests/kit1 version
AmoyDx® Essential NGS Panel24 tests/kit1 version
AmoyDx® EGFR 29 Mutations Detection Kit10 tests/kit1 version
AmoyDx® EGFR 29 Mutations Detection Kit24 tests/kit1 version
AmoyDx® KRAS Mutation Detection Kit6 tests/kit1 version
AmoyDx® KRAS Mutation Detection Kit24 tests/kit1 version
AmoyDx® BRAF V600 Mutations Detection Kit24 tests/kit1 version
AmoyDx® NRAS Mutation Detection Kit8 tests/kit1 version

48 families

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Browse all 48 products