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 20:14

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Device

3539415

Actor

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Certificate

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Active filter:Manufacturer SRN:US-MF-000018839

620 device results listed.

Page 29 / 31

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-81649002SCPS01LVY9
Basic UDI-DI
B-81649002SCPS01LVY9
Reference
SCPS01-AHG50E
EMDN
W01030799
EMDN description
HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
12.07.2026 10:05
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-81649002SCLS01KZWS
Basic UDI-DI
B-81649002SCLS01KZWS
Reference
SCLS01-AHG10E
EMDN
W0105900101
EMDN description
REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
12.07.2026 10:05
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-81649002RVZV01VNFD
Basic UDI-DI
B-81649002RVZV01VNFD
Reference
RVZV01-AHG5E
EMDN
W0105040904
EMDN description
VARICELLA ZOSTER - NA REAGENTS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
12.07.2026 10:05
D-81649002RNG01LEKY

RVZV01-AHG5E/RVZV01-AHG25E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-81649002RNG01LEKY
Basic UDI-DI
B-81649002RNG01LEKY
Reference
RNG01-AHG5E/ RNG01-AHG25E
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 10:05
D-81649002RHPV301RBBS

RHPV301-AHG5E/RHPV301-AHG25E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-81649002RHPV301RBBS
Basic UDI-DI
B-81649002RHPV301RBBS
Reference
RHPV301-AHG5E/RHPV301-AHG25E
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 10:05
D-81649002RHPV201R6AR

RHPV201-AHG5E/RHPV201-AHG25E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-81649002RHPV201R6AR
Basic UDI-DI
B-81649002RHPV201R6AR
Reference
RHPV201-AHG5E/RHPV201-AHG25E
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 10:05
D-81649002RGAS01JKST

RGAS01-AHG5E/ RGAS01-AHG25E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-81649002RGAS01JKST
Basic UDI-DI
B-81649002RGAS01JKST
Reference
RGAS01-AHG5E/ RGAS01-AHG25E
EMDN
W0105011103
EMDN description
STREP. A DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
12.07.2026 10:05
IVD generalIVDDOn the marketInstrumentMicrobial substancesProfessional testing
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-81649002MRQP06PN4S
Basic UDI-DI
B-81649002MRQP06PN4S
Reference
MRQP06-E
EMDN
W02050180
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
12.07.2026 10:05
IVD generalIVDDOn the marketInstrumentKitProfessional testing
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-81649002MRQP04PJ48
Basic UDI-DI
B-81649002MRQP04PJ48
Reference
MRQP04-E
EMDN
W02050180
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
12.07.2026 10:05
IVD generalIVDDOn the marketProfessional testingReagent
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-81649002MNAP01JGSA
Basic UDI-DI
B-81649002MNAP01JGSA
Reference
MNAP01
EMDN
W02050116
EMDN description
NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
12.07.2026 10:05
IVD generalIVDDOn the marketInstrumentProfessional testing
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-81649002MFIA02F7JY
Basic UDI-DI
B-81649002MFIA02F7JY
Reference
MFIA02-E
EMDN
W02050301
EMDN description
NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
12.07.2026 10:05
D-81649002ATP01HAFU

ATP01-AHG48E/ATP01-AHG96E/ATP01D-AHG48E/ATP01D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-81649002ATP01HAFU
Basic UDI-DI
B-81649002ATP01HAFU
Reference
ATP01-AHG48E/ATP01-AHG96E/ATP01D-AHG48E/ATP01D-AHG96E
EMDN
W0105010305
EMDN description
SYPHILIS DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
12.07.2026 10:04
D-81649002ATP01DFBL5

ATP01D-AHG48E/ATP01D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-81649002ATP01DFBL5
Basic UDI-DI
B-81649002ATP01DFBL5
Reference
ATP01D-AHG48E/ATP01D-AHG96E
EMDN
W0105010305
EMDN description
SYPHILIS DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
12.07.2026 10:04
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
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
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
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
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
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
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