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D-81649002ADZCOM01D7667

ADZCOM01D-AHG48E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002ADZCOM01D7667
Basic UDI-DI: B-81649002ADZCOM01D7667
Reference: ADZCOM01D-AHG48E
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors View details

Reveal Rapid HIV Test

815311000577 HIV POC

IVD Annex II List AIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: MedMira Laboratories Inc.
Manufacturer SRN: CA-MF-000013928
UDI-DI: D-81531100057769
Basic UDI-DI: B-81531100057769
Reference: 815311000577
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 12.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors View details

D-201059001020544Y

COVID-19 Nucleic Acid Detection Kit(Fluorescence PCR)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Beijing Healthgene Laboratory Co.,Ltd
Manufacturer SRN: CN-MF-000032465
UDI-DI: D-201059001020544Y
Basic UDI-DI: B-201059001020544Y
Reference: 100 Tests/Kit
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

D-101059001020433G

COVID-19 Nucleic Acid Detection Kit(Fluorescence PCR)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Beijing Healthgene Laboratory Co.,Ltd
Manufacturer SRN: CN-MF-000032465
UDI-DI: D-101059001020433G
Basic UDI-DI: B-101059001020433G
Reference: 50 Tests/Kit
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

PREP-GS DNA Extraction Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014362448
Basic UDI-DI: 466001436RA046XA
Reference: P-003/1EU
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

PREP-GS GENETICS DNA Extraction Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014362288
Basic UDI-DI: 466001436RA046XA
Reference: P-023/4EU
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

PREP-MB DWP DNA/RNA Extraction Kit, Package N

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

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014362981
Basic UDI-DI: 466001436RA072XB
Reference: Р-119-N/9EU
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

PREP-MB DWP DNA/RNA Extraction Kit, Package P Set No. 1

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

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014363018
Basic UDI-DI: 466001436RA072XB
Reference: Р-119-P/9EU
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

SOFTEC Magic-Auto Whole Blood DNA/RNA Isolation Kit

ZT-MAWB

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616343
Basic UDI-DI: B-08697962616343
Reference: ZT-MAWB-01-96
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:21

Manufacturer products View details

LyoSens Haemophilus Ducreyi Detection qPCR Kit

LYO81

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595034958
Basic UDI-DI: B-08684595034958
Reference: LYO81
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:16

Manufacturer products View details

RevoDx Stool Pathogen DNA/RNA Purification Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387215015
Basic UDI-DI: B-08684387215015
Reference: IP202428-100
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:03

Manufacturer products View details

RevoDx Stool Pathogen DNA/RNA Purification Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387215008
Basic UDI-DI: B-08684387215008
Reference: IP202428-50
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:03

Manufacturer products View details

RevoDx Stool Pathogen DNA/RNA Purification Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387214995
Basic UDI-DI: B-08684387214995
Reference: IP202428-25
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:03

Manufacturer products View details

RevoDx Magnetic Pathogen DNA/RNA Purification Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387214988
Basic UDI-DI: B-08684387214988
Reference: IP202303-100
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:03

Manufacturer products View details

RevoDx Magnetic Pathogen DNA/RNA Purification Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387214971
Basic UDI-DI: B-08684387214971
Reference: IP202303-50
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:03

Manufacturer products View details

RevoDx Pathogen DNA/RNA Purification Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387214940
Basic UDI-DI: B-08684387214940
Reference: IP202302-50
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:03

Manufacturer products View details

RevoDx Pathogen DNA/RNA Purification Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387214933
Basic UDI-DI: B-08684387214933
Reference: IP202302-25
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:03

Manufacturer products View details

RevoDx Magnetic Pathogen DNA/RNA Purification Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387214964
Basic UDI-DI: B-08684387214964
Reference: IP202303-25
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:03

Manufacturer products View details

RevoDx Pathogen DNA/RNA Purification Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387214957
Basic UDI-DI: B-08684387214957
Reference: IP202302-100
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:03

Manufacturer products View details

RevoDx Cervical Specimens Transport Reagent

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387214926
Basic UDI-DI: B-08684387214926
Reference: IP202219-100
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:03

Manufacturer products View details