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recomLine Anti-human IgG conjugate

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Mikrogen GmbH
Manufacturer SRN: DE-MF-000027747
UDI-DI: 04250571125602
Basic UDI-DI: 42505711B2101WG
Reference: 10074
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: -
Last updated: 23.09.2026 23:11

Manufacturer products View details

recomLine Dilution buffer

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Mikrogen GmbH
Manufacturer SRN: DE-MF-000027747
UDI-DI: 04250571125589
Basic UDI-DI: 42505711B2100WE
Reference: 10070
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: -
Last updated: 23.09.2026 23:11

Manufacturer products View details

recomLine Dilution buffer

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Mikrogen GmbH
Manufacturer SRN: DE-MF-000027747
UDI-DI: 04250571125572
Basic UDI-DI: 42505711B2100WE
Reference: 10062
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: -
Last updated: 23.09.2026 23:11

Manufacturer products View details

recomBlot Wash buffer C 5x

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Mikrogen GmbH
Manufacturer SRN: DE-MF-000027747
UDI-DI: 04250571125565
Basic UDI-DI: 42505711B2100WE
Reference: 10063
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: -
Last updated: 23.09.2026 23:11

Manufacturer products View details

recomBlot, recomLine Wash buffer A 10x

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Mikrogen GmbH
Manufacturer SRN: DE-MF-000027747
UDI-DI: 04250571125558
Basic UDI-DI: 42505711B2100WE
Reference: 10071
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: -
Authorised representative: -
Last updated: 23.09.2026 23:11

Manufacturer products View details

01220000260054

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260054
Basic UDI-DI: 122000026NATCDIHV
Reference: NATCDI-6MC-IVD
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 23.09.2026 23:00

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19/Flu A&B Rapid Antigen Test

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hecin Scientific, Inc.
Manufacturer SRN: CN-MF-000019106
UDI-DI: 06973349148013
Basic UDI-DI: 697334914RJ06MA
Reference: RJ06-1
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Germany
Authorised representative: Share info GmbH
Last updated: 23.09.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

01220000260023

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260023
Basic UDI-DI: 122000026NATCTM4
Reference: NATCT(434)-6MC-IVD
EMDN: W0105010117
EMDN description: CHLAMYDIA TRACHOMATIS DETECTION BY NA REAGENTS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 23.09.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5C

GSD01-1600-5C

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Gold Standard Diagnostics, LLC
Manufacturer SRN: US-MF-000027142
UDI-DI: B350GSD0116005C0
Basic UDI-DI: B-B350GSD0116005C0
Reference: GSD01-1600-5C
EMDN: W0105010399
EMDN description: SYPHILIS REAGENTS OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 23.09.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

01220000260030

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260030
Basic UDI-DI: 122000026NATNGMB
Reference: NATNG-6MC-IVD
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 23.09.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

01220000260047

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260047
Basic UDI-DI: 122000026NATCTNGR4
Reference: NATCTNGNEG-6MC-IVD
EMDN: W0105010117
EMDN description: CHLAMYDIA TRACHOMATIS DETECTION BY NA REAGENTS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 23.09.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

01220000260078

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260078
Basic UDI-DI: 122000026NATCXVA929
Reference: NATCXVA9-6C-IVD
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 23.09.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

01220000260085

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260085
Basic UDI-DI: 122000026NATFLUABYW
Reference: NATFLUAB-6C-IVD
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 23.09.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

01220000260092

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260092
Basic UDI-DI: 122000026NATRSVNF
Reference: NATRSV-6C-IVD
EMDN: W0105040505
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 23.09.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

01220000260108

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260108
Basic UDI-DI: 122000026NATNOVMF
Reference: NATNOV-6MC-IVD
EMDN: W0105040516
EMDN description: NOROVIRUS - NA REAGENTS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 23.09.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

01220000260139

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260139
Basic UDI-DI: 122000026NATROTATS
Reference: NATROTA-6MC-IVD
EMDN: W0105040516
EMDN description: NOROVIRUS - NA REAGENTS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 23.09.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

01220000260146

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260146
Basic UDI-DI: 122000026NATSAGKY
Reference: NATSAG-6MC-IVD
EMDN: W0105011105
EMDN description: STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 23.09.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

01220000260153

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260153
Basic UDI-DI: 122000026NATLACJM
Reference: NATLAC-6MC-IVD
EMDN: W0105011105
EMDN description: STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 23.09.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

01220000260184

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260184
Basic UDI-DI: 122000026NATTVPOS9L
Reference: NATTVPOS-6MC-IVD
EMDN: W0105050211
EMDN description: TRICHOMONAS - NA REAGENTS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 23.09.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

01220000260191

NATtrol™ Chlamydia trachomatis Positive Control Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: ZeptoMetrix LLC
Manufacturer SRN: US-MF-000035245
UDI-DI: 01220000260191
Basic UDI-DI: 122000026NATTVNEG7L
Reference: NATTVNEG-6MC-IVD
EMDN: W0105050211
EMDN description: TRICHOMONAS - NA REAGENTS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 23.09.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details