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EUDAMED Device Search

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

Last updated

20.08.2026 18:47

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587 device results listed.

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D-81649002APA01E37Y

APA01-AHG48E; APA01-AHG96E; APA01D-AHG48E; APA01D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002APA01E37Y
Basic UDI-DI: B-81649002APA01E37Y
Reference: APA01-AHG48E; APA01-AHG96E; APA01D-AHG48E; APA01D-AHG96E
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002ANG01EKAN

ANG01-AHG48E; ANG01-AHG96E; ANG01D-AHG48E; ANG01D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002ANG01EKAN
Basic UDI-DI: B-81649002ANG01EKAN
Reference: ANG01-AHG48E; ANG01-AHG96E; ANG01D-AHG48E; ANG01D-AHG96E
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002ANG01DBACU

ANG01D-AHG48E; ANG01D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002ANG01DBACU
Basic UDI-DI: B-81649002ANG01DBACU
Reference: ANG01D-AHG48E; ANG01D-AHG96E
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AMTBC01HNZE

AMTBC01-AHG48E; AMTBC01-AHG96E; AMTBC01D-AHG48E; AMTBC01D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AMTBC01HNZE
Basic UDI-DI: B-81649002AMTBC01HNZE
Reference: AMTBC01-AHG48E; AMTBC01-AHG96E; AMTBC01D-AHG48E; AMTBC01D-AHG96E
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AMTBC01DNVDE

AMTBC01D-AHG48E, AMTBC01D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AMTBC01DNVDE
Basic UDI-DI: B-81649002AMTBC01DNVDE
Reference: AMTBC01D-AHG48E, AMTBC01D-AHG96E
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AMPV01HGSL

AMPV01-AHG48E; AMPV01-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AMPV01HGSL
Basic UDI-DI: B-81649002AMPV01HGSL
Reference: AMPV01-AHG48E; AMPV01-AHG96E
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AMPV01DK32Z

AMPV01D-AHG48E; AMPV01D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AMPV01DK32Z
Basic UDI-DI: B-81649002AMPV01DK32Z
Reference: AMPV01D-AHG48E; AMPV01D-AHG96E
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AMP01FRDV

AMP01-AHG48E; AMP01-AHG96E; AMP01D-AHG48E; AMP01D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AMP01FRDV
Basic UDI-DI: B-81649002AMP01FRDV
Reference: AMP01-AHG48E; AMP01-AHG96E; AMP01D-AHG48E; AMP01D-AHG96E
EMDN: W010501080303
EMDN description: UREAPLASMA DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AMP01DCWHF

AMP01D-AHG48E; AMP01D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AMP01DCWHF
Basic UDI-DI: B-81649002AMP01DCWHF
Reference: AMP01D-AHG48E; AMP01D-AHG96E
EMDN: W010501080303
EMDN description: UREAPLASMA DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AKRAS01JF42

AKRAS01-AHG24E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AKRAS01JF42
Basic UDI-DI: B-81649002AKRAS01JF42
Reference: AKRAS01-AHG24E
EMDN: W01060202
EMDN description: K-RAS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AIAH501DC9SA

AIAH501D-AHG48E; AIAH501D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AIAH501DC9SA
Basic UDI-DI: B-81649002AIAH501DC9SA
Reference: AIAH501D-AHG48E; AIAH501D-AHG96E
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AHSV201H6X4

AHSV201-AHG48E; AHSV201-AHG96E; AHSV201D-AHG48E; AHSV201D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AHSV201H6X4
Basic UDI-DI: B-81649002AHSV201H6X4
Reference: AHSV201-AHG48E; AHSV201-AHG96E; AHSV201D-AHG48E; AHSV201D-AHG96E
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AHSV201DP7BN

AHSV201D-AHG48E; AHSV201D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AHSV201DP7BN
Basic UDI-DI: B-81649002AHSV201DP7BN
Reference: AHSV201D-AHG48E; AHSV201D-AHG96E
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AHSV101GZYU

AHSV101-AHG48E; AHSV101-AHG96E; AHSV101D-AHG48E; AHSV101D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AHSV101GZYU
Basic UDI-DI: B-81649002AHSV101GZYU
Reference: AHSV101-AHG48E; AHSV101-AHG96E; AHSV101D-AHG48E; AHSV101D-AHG96E
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AHPV2301M87N

AHPV2301-AHG48E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AHPV2301M87N
Basic UDI-DI: B-81649002AHPV2301M87N
Reference: AHPV2301-AHG48E
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AHPV2301DURR7

AHPV2301D-AHG48E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AHPV2301DURR7
Basic UDI-DI: B-81649002AHPV2301DURR7
Reference: AHPV2301D-AHG48E
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AHPV1801MSAL

AHPV1801-BHG48E,AHPV1801-BHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AHPV1801MSAL
Basic UDI-DI: B-81649002AHPV1801MSAL
Reference: AHPV1801-BHG48E,AHPV1801-BHG96E
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AHPV1801AVBRB

AHPV1801-AHG48E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AHPV1801AVBRB
Basic UDI-DI: B-81649002AHPV1801AVBRB
Reference: AHPV1801-AHG48E
EMDN: W0105041005
EMDN description: OTHER HPV - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AHPV1801-C6P8A

AHPV1801-CHG48E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AHPV1801-C6P8A
Basic UDI-DI: B-81649002AHPV1801-C6P8A
Reference: AHPV1801-CHG48E
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AHPV1401M67G

AHPV1401-AHG48E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AHPV1401M67G
Basic UDI-DI: B-81649002AHPV1401M67G
Reference: AHPV1401-AHG48E
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:00

Manufacturer products Authorised representative products Authorised representative actors View details