Public EUDAMED Search

EUDAMED Device Search

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

Last updated

22.09.2026 01:15

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Active filter:EMDN:W01010236

7 device results listed.

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480 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671100342
Basic UDI-DI: B-06974671100342
Reference: DR-NS-A002
EMDN: W01010236
EMDN description: PHENYLKETONURIA
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:07

Manufacturer products Authorised representative products Authorised representative actors View details

Phenylalanine (PKU) neonatal Screening Assay

Phenylalanine (PKU) neonatal Screening Assay

IVD Annex II List BIVDDNo longer on the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325004573
Basic UDI-DI: B-04049325004573
Reference: RE80019
EMDN: W01010236
EMDN description: PHENYLKETONURIA
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:10

Manufacturer products View details

Neonatal Phenylalanine

-

IVD Annex II List BNot specifiedOn the market

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06438172085015
Basic UDI-DI: B-06438172085015
Reference: 6199896
EMDN: W01010236
EMDN description: PHENYLKETONURIA
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:39

Manufacturer products View details

GSP Neonatal Phenylalanine kit

-

IVD Annex II List BNot specifiedOn the market

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147324514
Basic UDI-DI: B-06438147324514
Reference: 3308-0010
EMDN: W01010236
EMDN description: PHENYLKETONURIA
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:36

Manufacturer products View details

GSP Neonatal Phenylalanine kit

-

IVD Annex II List BNot specifiedOn the market

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147324507
Basic UDI-DI: B-06438147324507
Reference: 3308-001B
EMDN: W01010236
EMDN description: PHENYLKETONURIA
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:36

Manufacturer products View details

Neonatal Phenylalanine

-

IVD Annex II List BNot specifiedOn the market

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147001293
Basic UDI-DI: B-06438147001293
Reference: NP-4000
EMDN: W01010236
EMDN description: PHENYLKETONURIA
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:34

Manufacturer products View details

Neonatal Phenylalanine

-

IVD Annex II List BNot specifiedOn the market

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147001286
Basic UDI-DI: B-06438147001286
Reference: NP-1000
EMDN: W01010236
EMDN description: PHENYLKETONURIA
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:34

Manufacturer products View details