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634 device results listed.

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Easy@Home Pregnancy Test

EZW1-S-20

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-EZW1-S-20CD
Basic UDI-DI: B-EZW1-S-20CD
Reference: EZW1-S-20
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

Easy @ Home Pregnancy Test

EZW1-MN-5

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-EZW1-MN-5FW
Basic UDI-DI: B-EZW1-MN-5FW
Reference: EZW1-MN-5
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

Easy @ Home Pregnancy Test

EZW1-MN-2

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-EZW1-MN-2FQ
Basic UDI-DI: B-EZW1-MN-2FQ
Reference: EZW1-MN-2
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

Easy @ Home Pregnancy Test

EZM1-H3

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-EZM1-H3YP
Basic UDI-DI: B-EZM1-H3YP
Reference: EZM1-H3
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

Saliva Alcohol Test Strip

DAL-701a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-DAL-701a3J
Basic UDI-DI: B-DAL-701a3J
Reference: DAL-701a
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 16:02

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Detection Kit (Fluorescence PCR)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-AMPV01FJ
Basic UDI-DI: B-AMPV01FJ
Reference: AMPV01-AOG48E, AMPV01-AOG96E, AMPV01D-AOG48E, AMPV01D-AOG96E
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 21:35

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Multi-Drug Test Dip Card (Urine)

GBDOA-144-008

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

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996098434
Basic UDI-DI: 69509960GBDOA144008ZL
Reference: GBDOA-144-008
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 09:34

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Multi-Drug Test Dip Card (Urine)

GBDOA-1104-030

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

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996096119
Basic UDI-DI: 69509960GBDOA1104030GZ
Reference: GBDOA-1104-030
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 09:34

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Multi-Drug Test Dip Card (Urine)

GBDOA-1124-009

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

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996095174
Basic UDI-DI: 69509960GBDOA1124009HY
Reference: GBDOA-1124-009
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 09:34

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Multi-Drug Test Dip Card (Urine)

GBDOA-184-005

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

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996091909
Basic UDI-DI: 69509960GBDOA1840052V
Reference: GBDOA-184-005
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 09:34

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extraction Reagent

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996091565
Basic UDI-DI: 69509960N3001BE7
Reference: N3001B
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 09:34

Manufacturer products Authorised representative products Authorised representative actors View details

Fecal Occult Blood and Transferrin Combo Rapid Test Device (Feces)

GEFT-T606a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996090780
Basic UDI-DI: B-06950996090780
Reference: GEFT-T606a
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:34

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Multi-Drug Test Dip Card (Urine)

GBDOA-1104-029

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

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996087209
Basic UDI-DI: 69509960GBDOA1104029HG
Reference: GBDOA-1104-029
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 09:34

Manufacturer products Authorised representative products Authorised representative actors View details

Fecal Occult Blood Rapid Test Device (Feces)

GEFOB-606b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996071161
Basic UDI-DI: B-06950996071161
Reference: GEFOB-606b
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:34

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Multi-Drug Test Dip Card (Urine)

GBDOA-1114-002

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

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996070423
Basic UDI-DI: 69509960GBDOA1114002H7
Reference: GBDOA-1114-002
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 09:34

Manufacturer products Authorised representative products Authorised representative actors View details

Cell Preservation Solution

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996066686
Basic UDI-DI: 69509960N3003BED
Reference: N3003B
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 09:34

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Multi-Drug Test Dip Card (Urine)

GBDOA-144-009

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

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996065078
Basic UDI-DI: 69509960GBDOA144009ZN
Reference: GBDOA-144-009
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 09:34

Manufacturer products Authorised representative products Authorised representative actors View details

Mini Immunofluorescence Analyzer

OG-H101

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: 06950996064866
Basic UDI-DI: 69509960OG-H101MF
Reference: OG-H101
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 09:34

Manufacturer products Authorised representative products Authorised representative actors View details

Liver Function Lyophilized Kit 14

LF-001

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996064187
Basic UDI-DI: B-06950996064187
Reference: LF-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 09:34

Manufacturer products Authorised representative products Authorised representative actors View details

General Chemistry III Lyophilized Kit 15

SYN-003

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996063890
Basic UDI-DI: B-06950996063890
Reference: SYN-003
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 09:34

Manufacturer products Authorised representative products Authorised representative actors View details