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EUDAMED Device Search

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

Last updated

21.09.2026 21:15

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++G226DX243500+

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IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Norgen Biotek Corporation
Manufacturer SRN: CA-MF-000024034
UDI-DI: ++G226DX243500+
Basic UDI-DI: ++G226TotalRNAPKitT5
Reference: Dx24350
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

++G226DX253000.

FFPE RNA Purification Kit Dx

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Norgen Biotek Corporation
Manufacturer SRN: CA-MF-000024034
UDI-DI: ++G226DX253000.
Basic UDI-DI: ++G226FFPERNAPKitGK
Reference: Dx25300
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

++G226DX276000%

Stool DNA Isolation Kit Dx

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Norgen Biotek Corporation
Manufacturer SRN: CA-MF-000024034
UDI-DI: ++G226DX276000%
Basic UDI-DI: ++G226StoolDNAIKitTD
Reference: Dx27600
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

++G226DX428000+

Plasma/Serum Circulating and Exosomal RNA Purification Kit Dx (Slurry Format)

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Norgen Biotek Corporation
Manufacturer SRN: CA-MF-000024034
UDI-DI: ++G226DX428000+
Basic UDI-DI: ++G226PlaSercfexRNAPKitCC
Reference: Dx42800
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

++G226DX454000/

Saliva DNA Isolation Kit Dx

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Norgen Biotek Corporation
Manufacturer SRN: CA-MF-000024034
UDI-DI: ++G226DX454000/
Basic UDI-DI: ++G226SalivaDNAIKit22
Reference: Dx45400
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

++G226DX463000/

Blood Genomic DNA Isolation Mini Kit Dx

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Norgen Biotek Corporation
Manufacturer SRN: CA-MF-000024034
UDI-DI: ++G226DX463000/
Basic UDI-DI: ++G226BloodgDNAIKitPU
Reference: Dx46300
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

++G226DX474000%

FFPE DNA Purification Kit Dx

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Norgen Biotek Corporation
Manufacturer SRN: CA-MF-000024034
UDI-DI: ++G226DX474000%
Basic UDI-DI: ++G226FFPEDNAPKit95
Reference: Dx47400
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

++G226DX4880004

Urine DNA Isolation Kit Dx

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Norgen Biotek Corporation
Manufacturer SRN: CA-MF-000024034
UDI-DI: ++G226DX4880004
Basic UDI-DI: ++G226UriDNAIsoKitX5
Reference: Dx48800
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

++G226DX4950002

Stool Total RNA Purification Kit Dx

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Norgen Biotek Corporation
Manufacturer SRN: CA-MF-000024034
UDI-DI: ++G226DX4950002
Basic UDI-DI: ++G226StoolTotRNAPKitNX
Reference: Dx49500
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

++G226DX506000_

Plasma/Serum Circulating DNA Purification Mini Kit Dx (Slurry Format)

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Norgen Biotek Corporation
Manufacturer SRN: CA-MF-000024034
UDI-DI: ++G226DX506000_
Basic UDI-DI: ++G226PlaSercfDNAPKitJK
Reference: Dx50600
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

++G226DX543000$

FFPE RNA/DNA Purification Plis Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Norgen Biotek Corporation
Manufacturer SRN: CA-MF-000024034
UDI-DI: ++G226DX543000$
Basic UDI-DI: ++G226FFPERNADNAPKit4S
Reference: Dx54300
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

++G226DX551000_

Plasma/Serum Cell-Free Circulating Purification Kit Dx

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Norgen Biotek Corporation
Manufacturer SRN: CA-MF-000024034
UDI-DI: ++G226DX551000_
Basic UDI-DI: ++G226PlaSercfcDNAPKitXA
Reference: Dx55100
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

++G226DX555000%

-

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Norgen Biotek Corporation
Manufacturer SRN: CA-MF-000024034
UDI-DI: ++G226DX555000%
Basic UDI-DI: ++G226PlaSercfcDNAPKitXA
Reference: Dx55500
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

++G226DX5560000

-

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Norgen Biotek Corporation
Manufacturer SRN: CA-MF-000024034
UDI-DI: ++G226DX5560000
Basic UDI-DI: ++G226PlaSercfcDNAPKitXA
Reference: Dx55600
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

++G226DX5580002

-

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Norgen Biotek Corporation
Manufacturer SRN: CA-MF-000024034
UDI-DI: ++G226DX5580002
Basic UDI-DI: ++G226PlaSercfcDNAPKitXA
Reference: Dx55800
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

++G226DX6910000*

Saliva/Swab RNA Purification Kit Dx

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Norgen Biotek Corporation
Manufacturer SRN: CA-MF-000024034
UDI-DI: ++G226DX6910000*
Basic UDI-DI: ++G226SalivaSwabRNAPKitVL
Reference: Dx69100
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

MBTREK-01 MBTREK-02

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459000224
Basic UDI-DI: 8905459RNAEXTAU
Reference: MBTREK-01 MBTREK-02
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

800971

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019711152
Basic UDI-DI: 888501971800971XQ
Reference: 800971
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 01.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

800841

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710995
Basic UDI-DI: 888501971800841XA
Reference: 800841
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 01.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

800814

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710964
Basic UDI-DI: 888501971800814X7
Reference: 800814
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 01.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details