Public EUDAMED Search

EUDAMED Device Search

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

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Last updated

07.07.2026 06:14

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60 device results listed.

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06977211620195

IVD Class ANot specifiedOn the market

Manufacturer: Hangzhou HealthSky Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000040002
UDI-DI: 06977211620195
Basic UDI-DI: 697721162HSCPVMM
Reference: FCA01-JA
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

06977211620201

IVD Class ANot specifiedOn the market

Manufacturer: Hangzhou HealthSky Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000040002
UDI-DI: 06977211620201
Basic UDI-DI: 697721162HSSUPS
Reference: FCS-4A
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

06977211620218

IVD Class ANot specifiedOn the market

Manufacturer: Hangzhou HealthSky Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000040002
UDI-DI: 06977211620218
Basic UDI-DI: 697721162HSDIMM
Reference: FDA01-MT
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

06977211620225

IVD Class ANot specifiedOn the market

Manufacturer: Hangzhou HealthSky Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000040002
UDI-DI: 06977211620225
Basic UDI-DI: 697721162HSDTNB
Reference: FCD-5A
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

06977211624506

FCS-4A FCS-4B

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Hangzhou HealthSky Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000040002
UDI-DI: 06977211624506
Basic UDI-DI: 697721162HSSUPS
Reference: FCS-4A
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

06977211620065

PSS-05A、PSS-80A、PSS-120A、PSS-160A、PSS-320A、PSS-480A PSS-05B、PSS-80B、PSS-120B、PSS-160B、PSS-320B、PSS-480B

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou HealthSky Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000040002
UDI-DI: 06977211620065
Basic UDI-DI: 697721162IWSISQH
Reference: PSS-05A
EMDN: W0202050301
EMDN description: ELECTRON MICROSCOPES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

06977211629006

FASS-1280A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou HealthSky Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000040002
UDI-DI: 06977211629006
Basic UDI-DI: 697721162HSFASSPF
Reference: FASS-1280A
EMDN: W0202059099
EMDN description: VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:20

Manufacturer products Authorised representative products Authorised representative actors View details

06977211628504

ATP-96A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou HealthSky Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000040002
UDI-DI: 06977211628504
Basic UDI-DI: 697721162HSATPSR2
Reference: ATP-96A
EMDN: W0202059004
EMDN description: TISSUE EMBEDDING PROCESSORS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:20

Manufacturer products Authorised representative products Authorised representative actors View details

06977211628009

FCP-5T

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Hangzhou HealthSky Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000040002
UDI-DI: 06977211628009
Basic UDI-DI: 697721162HSSFKNH
Reference: FCP-5T
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:20

Manufacturer products Authorised representative products Authorised representative actors View details

06977211627507

FRA01-QT

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Hangzhou HealthSky Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000040002
UDI-DI: 06977211627507
Basic UDI-DI: 697721162HSPPSPG
Reference: FRA01-QT
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:20

Manufacturer products Authorised representative products Authorised representative actors View details

06977211627002

FLA01-MT

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Hangzhou HealthSky Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000040002
UDI-DI: 06977211627002
Basic UDI-DI: 697721162HSLSNZ
Reference: FLA01-MT
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:20

Manufacturer products Authorised representative products Authorised representative actors View details

06977211626500

FCD-5A

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Hangzhou HealthSky Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000040002
UDI-DI: 06977211626500
Basic UDI-DI: 697721162HSDTNB
Reference: FCD-5A
EMDN: W0503020201
EMDN description: PIPETTE TIPS WITH FILTER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:20

Manufacturer products Authorised representative products Authorised representative actors View details

06977211626005

FDA01-MT

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Hangzhou HealthSky Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000040002
UDI-DI: 06977211626005
Basic UDI-DI: 697721162HSDIMM
Reference: FDA01-MT
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:20

Manufacturer products Authorised representative products Authorised representative actors View details

06977211625503

FCA03-DT

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Hangzhou HealthSky Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000040002
UDI-DI: 06977211625503
Basic UDI-DI: 697721162HSCPSMF
Reference: FCA03-DT
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:20

Manufacturer products Authorised representative products Authorised representative actors View details

06977211625008

FBA01-MT

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Hangzhou HealthSky Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000040002
UDI-DI: 06977211625008
Basic UDI-DI: 697721162HSBUN7
Reference: FBA01-MT
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:20

Manufacturer products Authorised representative products Authorised representative actors View details

Healtshsky

EMarker-11A-S100, EMarker-21A-S100

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou HealthSky Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000040002
UDI-DI: 06977211623042
Basic UDI-DI: 697721162HSLSPNX
Reference: EMarker-11A-S100
EMDN: W0202059017
EMDN description: CASSETTE / SLIDE PRINTERS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:20

Manufacturer products Authorised representative products Authorised representative actors View details

Healtshsky

EBMarker-160

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou HealthSky Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000040002
UDI-DI: 06977211623004
Basic UDI-DI: 697721162HSMHLCPZ8
Reference: EBMarker-160
EMDN: W0202059017
EMDN description: CASSETTE / SLIDE PRINTERS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:20

Manufacturer products Authorised representative products Authorised representative actors View details

06977211624001

FCA01-JA FCA01-JB FCA02-NT FCA03-JT FCA03-PT

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Hangzhou HealthSky Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000040002
UDI-DI: 06977211624001
Basic UDI-DI: 697721162HSCPVMM
Reference: FCA01-JA
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:20

Manufacturer products Authorised representative products Authorised representative actors View details

Healthsky

FPA01-AT FPA02-ET FPA02-FT FPA01-ET FPA02-GT FPA01-BT FPA02-MT

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou HealthSky Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000040002
UDI-DI: 06977211622007
Basic UDI-DI: 697721162HSPSKP9
Reference: FPA01-AT
EMDN: W01030708
EMDN description: STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:20

Manufacturer products Authorised representative products Authorised representative actors View details

Healthsky

FGA01-1B

IVD Class AIVDR 2017/746On the marketKitReagentSingle use

Manufacturer: Hangzhou HealthSky Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000040002
UDI-DI: 06977211621055
Basic UDI-DI: 697721162HSELBCPKB2
Reference: FGA01-1B
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:19

Manufacturer products Authorised representative products Authorised representative actors View details