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620 device results listed.

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One Step Multi-Drug Screen Test Cup (Urine)

GBDOA-1X6

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GBDOA-1X6HGU8
Basic UDI-DI: B-GBDOA-1X6HGU8
Reference: GBDOA-1X6
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:15

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Multi-Drug Screen Test Cup (Urine)

GBDOA-1X6-ALC

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GBDOA-1X6-ALCHGJP
Basic UDI-DI: B-GBDOA-1X6-ALCHGJP
Reference: GBDOA-1X6-ALC
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:15

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Multi-Drug Screen Test Cassette (Urine)

GBDOA-1X5

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GBDOA-1X5HGU3
Basic UDI-DI: B-GBDOA-1X5HGU3
Reference: GBDOA-1X5
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:15

Manufacturer products Authorised representative products Authorised representative actors View details

Drugs of Abuse Rapid Test Cassette (Hair)

GBDOA-11X5

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GBDOA-11X5HGQQ
Basic UDI-DI: B-GBDOA-11X5HGQQ
Reference: GBDOA-11X5
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:15

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Cotinine Test Cassette (Urine)

GBCOT-102a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GBCOT-102aHGYL
Basic UDI-DI: B-GBCOT-102aHGYL
Reference: GBCOT-102a
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:15

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Cotinine Test Strip (Urine)

GBCOT-101a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GBCOT-101aHGYD
Basic UDI-DI: B-GBCOT-101aHGYD
Reference: GBCOT-101a
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:15

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Benzodiazepines Test Cassette (Urine)

GBBZO-102a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GBBZO-102aHG4Q
Basic UDI-DI: B-GBBZO-102aHG4Q
Reference: GBBZO-102a
EMDN: W0102160504
EMDN description: BENZODIAZEPINES - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:15

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Benzodiazepines Test Strip (Urine)

GBBZO-101a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GBBZO-101aHG4H
Basic UDI-DI: B-GBBZO-101aHG4H
Reference: GBBZO-101a
EMDN: W0102160504
EMDN description: BENZODIAZEPINES - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:15

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Buprenorphine Test Cassette (Urine)

GBBUP-102a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GBBUP-102aHGZM
Basic UDI-DI: B-GBBUP-102aHGZM
Reference: GBBUP-102a
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:15

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Buprenorphine Test Strip (Urine)

GBBUP-101a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GBBUP-101aHGZE
Basic UDI-DI: B-GBBUP-101aHGZE
Reference: GBBUP-101a
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:15

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Barbiturates Test Cassette (Urine)

GBBAR-102a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GBBAR-102aHGLF
Basic UDI-DI: B-GBBAR-102aHGLF
Reference: GBBAR-102a
EMDN: W0102160503
EMDN description: BARBITURATES - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:15

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Barbiturates Test Strip (Urine)

GBBAR-101a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GBBAR-101aHGL8
Basic UDI-DI: B-GBBAR-101aHGL8
Reference: GBBAR-101a
EMDN: W0102160503
EMDN description: BARBITURATES - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:15

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Amphetamine Test Strip (Urine)

GBAMP-101a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GBAMP-101aHGSR
Basic UDI-DI: B-GBAMP-101aHGSR
Reference: GBAMP-101a
EMDN: W0102160501
EMDN description: AMPHETAMINES - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:15

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Alcohol Test Dip Card

GBALC-105a

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GBALC-105aHGK7
Basic UDI-DI: B-GBALC-105aHGK7
Reference: GBALC-105a
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:15

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Alcohol Test Strip

GBALC-101a

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GBALC-101aHGJB
Basic UDI-DI: B-GBALC-101aHGJB
Reference: GBALC-101a
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:15

Manufacturer products Authorised representative products Authorised representative actors View details

Male Fertility Rapid Test Cassette (Semen)

GASPE-902a

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GASPE-902aHG9A
Basic UDI-DI: B-GASPE-902aHG9A
Reference: GASPE-902a
EMDN: W0102050199
EMDN description: FERTILITY FUNCTION HORMONES - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

LH Ovulation Rapid Test

GALH-103b-5T

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GALH-103b-5THGNX
Basic UDI-DI: B-GALH-103b-5THGNX
Reference: GALH-103b-5T
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

LH Ovulation Rapid Test

GALH-103b-2T

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GALH-103b-2THGNA
Basic UDI-DI: B-GALH-103b-2THGNA
Reference: GALH-103b-2T
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

LH Ovulation Rapid Test

GALH-103b-25T

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GALH-103b-25THGTR
Basic UDI-DI: B-GALH-103b-25THGTR
Reference: GALH-103b-25T
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

LH Ovulation Rapid Test

GALH-103b-1T

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GALH-103b-1THGN3
Basic UDI-DI: B-GALH-103b-1THGN3
Reference: GALH-103b-1T
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details