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609 device results listed.

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One Step Multi-Drug Test Dip Card (Urine)

GBDOA-174-006

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996045278
Basic UDI-DI: 69509960GBDOA1740062L
Reference: GBDOA-174-006
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Portugal
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Multi-Drug Test Dip Card (Urine)

GBDOA-1144-002

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996041393
Basic UDI-DI: 69509960GBDOA1144002J8
Reference: GBDOA-1144-002
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Portugal
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extraction Reagent (Magnetic beads)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996040211
Basic UDI-DI: 69509960N3002DEE
Reference: N3002D
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Biochemistry Analyzer

Diag-H200

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996035330
Basic UDI-DI: 69509960Diag-H200DS
Reference: Diag-H200
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Multi-Drug Test Dip Card (Urine)

GBDOA-1104-001

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996033060
Basic UDI-DI: 69509960GBDOA1104001GS
Reference: GBDOA-1104-001
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Portugal
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extraction Reagent (Magnetic beads)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996032537
Basic UDI-DI: 69509960N3002CEC
Reference: N3002C
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Multi-Drug Test Dip Card (Urine)

GBDOA-134-019

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996026468
Basic UDI-DI: 69509960GBDOA134019ZE
Reference: GBDOA-134-019
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Portugal
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Strip (Throat Swab)

GCSTR-501a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996025713
Basic UDI-DI: B-06950996025713
Reference: GCSTR-501a
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Multi-Drug Test Dip Card (Urine)

GBDOA-134-002

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996020916
Basic UDI-DI: 69509960GBDOA134002YV
Reference: GBDOA-134-002
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Portugal
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

Renal Function Glucose and Lipid Lyophilized Kit 10

KF-002

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996019323
Basic UDI-DI: B-06950996019323
Reference: KF-002
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Multi-Drug Test Dip Card (Urine)

GBDOA-144-007

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996017169
Basic UDI-DI: 69509960GBDOA144007ZJ
Reference: GBDOA-144-007
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Portugal
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-channel Immunofluorescence Analyzer

OG-G260C

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996014731
Basic UDI-DI: 69509960OG-G260CS9
Reference: OG-G260C
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

Myocardial Enzyme and Lipid Lyophilized Kit 10

CAR-001

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996012164
Basic UDI-DI: B-06950996012164
Reference: CAR-001
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

General Chemistry II Lyophilized Kit 18

SYN-002

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996008808
Basic UDI-DI: B-06950996008808
Reference: SYN-002
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

06950996008259

Mplex-M100

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996008259
Basic UDI-DI: 69509960Mplex-M100DT
Reference: M-FLA-201-01
EMDN: W02020499
EMDN description: FLOW CYTOMETRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

General Chemistry I Lyophilized Kit 18

SYN-001

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996006644
Basic UDI-DI: B-06950996006644
Reference: SYN-001
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996004541
Basic UDI-DI: B-06950996004541
Reference: N7001B
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996004534
Basic UDI-DI: B-06950996004534
Reference: N7001A
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Detection Kit for Respiratory Tract Infection Pathogens (8 Types)(Flowcytometry Fluorescence Hybridization Method)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996004527
Basic UDI-DI: B-06950996004527
Reference: 2RYT8A11
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Detection Kit for Reproductive Tract Infection Pathogens (9 Types)(Flowcytometry Fluorescence Hybridization Method)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996004510
Basic UDI-DI: B-06950996004510
Reference: 2RET9A11
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details