Public EUDAMED Search

EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

05.07.2026 12:46

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2 device results listed.

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HI-P01

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Skyla Corporation Hsinchu Science Park Branch
Manufacturer SRN: TW-MF-000007751
UDI-DI: 04719878650021
Basic UDI-DI: 471987865801-000VN
Reference: 801-000
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 02.07.2026 00:19

HB-P02

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Skyla Corporation Hsinchu Science Park Branch
Manufacturer SRN: TW-MF-000007751
UDI-DI: 04719878650014
Basic UDI-DI: 471987865800-001AVW
Reference: 800-001A
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 02.07.2026 00:19