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669 device results listed.

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Urine Alcohol Test Strip

GBALC-101a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBALC-101aOGJY
Basic UDI-DI: B-GBALC-101aOGJY
Reference: GBALC-101a
EMDN: W0102090207
EMDN description: ETHANOL (ALCOHOL)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 05:03

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960SNCE07XHBY

SNCE07-AOG50E

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960SNCE07XHBY
Basic UDI-DI: B-69509960SNCE07XHBY
Reference: SNCE07-AOG50E
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: 17.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960SNCE05XDBE

SNCE05-BOG48E

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960SNCE05XDBE
Basic UDI-DI: B-69509960SNCE05XDBE
Reference: SNCE05-BOG48E
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: 17.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960SNCE01X59W

SNCE01-AOG48/ SNCE01-AOG96/ SNCE02-AOG16/ SNCE02-AOG48/ SNCE02-AOG96

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960SNCE01X59W
Basic UDI-DI: B-69509960SNCE01X59W
Reference: SNCE01-AOG48/ SNCE01-AOG96/ SNCE02-AOG16/ SNCE02-AOG48/ SNCE02-AOG96
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: 17.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960SMTB0125BS

SMTB01-AHG5E,SMTB01-AHG25E, SMTB01-BHG5E, SMTB01-BHG25E

IVD generalIVDDOn the marketInstrumentKitMicrobial substancesProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960SMTB0125BS
Basic UDI-DI: B-69509960SMTB0125BS
Reference: SMTB01-AHG5E,SMTB01-AHG25E, SMTB01-BHG5E, SMTB01-BHG25E
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960SDVS0125DN

SDVS01-AOG50E; SDVS01-BOG50E; SDVS01-COG50E; SDVS01-DOG50E

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960SDVS0125DN
Basic UDI-DI: B-69509960SDVS0125DN
Reference: SDVS01-AOG50E; SDVS01-BOG50E; SDVS01-COG50E; SDVS01-DOG50E
EMDN: W050301020280
EMDN description: SAMPLES ANALYSES, PLASTIC MICROTUBES - ACCESSORIES
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960SDSM01YFEX

SDSM01-AOG50E

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960SDSM01YFEX
Basic UDI-DI: B-69509960SDSM01YFEX
Reference: SDSM01-AOG50E
EMDN: W050180
EMDN description: SAMPLES COLLECTION DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960SDCSM014AQX

SDCSM01-AOG50E

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960SDCSM014AQX
Basic UDI-DI: B-69509960SDCSM014AQX
Reference: SDCSM01-AOG50E
EMDN: W050180
EMDN description: SAMPLES COLLECTION DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960RMTB01ZMGA

RMTB01-AHG5E, RMTB01-AHG25E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960RMTB01ZMGA
Basic UDI-DI: B-69509960RMTB01ZMGA
Reference: RMTB01-AHG5E, RMTB01-AHG25E
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960MRQP0435F2

PSR-MRQP04

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960MRQP0435F2
Basic UDI-DI: B-69509960MRQP0435F2
Reference: MRQP04-AOGE
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960MNAP01VYBB

MNAP01-AOGE

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960MNAP01VYBB
Basic UDI-DI: B-69509960MNAP01VYBB
Reference: MNAP01-AOGE
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960APA01PVQB

AFR01-AOG48E; AFR01-AOG96E; AFR01D-AOG48E; AFR01D-AOG96E

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960APA01PVQB
Basic UDI-DI: B-69509960APA01PVQB
Reference: AFR01-AOG48E; AFR01-AOG96E; AFR01D-AOG48E; AFR01D-AOG96E
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: 17.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960ANG01QDQJ

ANG01-AOG48E;,ANG01-AOG96E,ANG01D-AOG48E, ANG01D-AOG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960ANG01QDQJ
Basic UDI-DI: B-69509960ANG01QDQJ
Reference: ANG01-AOG48E;,ANG01-AOG96E,ANG01D-AOG48E, ANG01D-AOG96E
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960AMTBZK01DJEZ

AMTBZK01-AHG2E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960AMTBZK01DJEZ
Basic UDI-DI: B-69509960AMTBZK01DJEZ
Reference: AMTBZK01-AHG2E
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960AMTBC01WULG

AMTBC01-AOG48E； AMTBC01-AOG96E；AMTBC01D-AOG48E； AMTBC01D-AOG96E；

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960AMTBC01WULG
Basic UDI-DI: B-69509960AMTBC01WULG
Reference: AMTBC01-AOG48E； AMTBC01-AOG96E；AMTBC01D-AOG48E； AMTBC01D-AOG96E；
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960AMPV01UYBQ

AMPV01-AOG48E; AMPV01-AOG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960AMPV01UYBQ
Basic UDI-DI: B-69509960AMPV01UYBQ
Reference: AMPV01-AOG48E; AMPV01-AOG96E
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960AMP01RKTR

AMP01-AOG48E; AMP01-AOG96E; AMP01D-AOG48E; AMP01D-AOG96E

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960AMP01RKTR
Basic UDI-DI: B-69509960AMP01RKTR
Reference: AMP01-AOG48E; AMP01-AOG96E; AMP01D-AOG48E; AMP01D-AOG96E
EMDN: W010501080301
EMDN description: MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960AHSV201WCJG

AHSV201-AOG48E; AHSV201-AOG96E; AHSV201D-AOG48E; AHSV201D-AOG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960AHSV201WCJG
Basic UDI-DI: B-69509960AHSV201WCJG
Reference: AHSV201-AOG48E; AHSV201-AOG96E; AHSV201D-AOG48E; AHSV201D-AOG96E
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960AHSV101W7HF

AHSV101-AOG48E; AHSV101-AOG96E; AHSV101D-AOG48E; AHSV101D-AOG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960AHSV101W7HF
Basic UDI-DI: B-69509960AHSV101W7HF
Reference: AHSV101-AOG48E; AHSV101-AOG96E; AHSV101D-AOG48E; AHSV101D-AOG96E
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960AHPV23013ZTB

AHPV2301-AOG48E,AHPV2301-AOG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960AHPV23013ZTB
Basic UDI-DI: B-69509960AHPV23013ZTB
Reference: AHPV2301-AOG48E,AHPV2301-AOG96E
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: 17.07.2026 03:52

Manufacturer products Authorised representative products Authorised representative actors View details