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Micro-Albumin Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: D-L11-ALBS01A1VJ
Basic UDI-DI: B-L11-ALBS01A1VJ
Reference: L11-ALBS01A1
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.10.2026 11:10

Manufacturer products Authorised representative products Authorised representative actors View details

Micro-Albumin Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: D-L11-ALB01A1QC
Basic UDI-DI: B-L11-ALB01A1QC
Reference: L11-ALB01A1
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.10.2026 11:10

Manufacturer products Authorised representative products Authorised representative actors View details

AFP Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: D-L11-AFP01C4T4
Basic UDI-DI: B-L11-AFP01C4T4
Reference: L11-AFP01C4
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.10.2026 11:10

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Adenovirus Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: D-L11-AD01C6W3
Basic UDI-DI: B-L11-AD01C6W3
Reference: L11-AD01C6
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.10.2026 11:10

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Adenovirus pneumoniae Antigen Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: D-L11-AD01C5VZ
Basic UDI-DI: B-L11-AD01C5VZ
Reference: L11-AD01C5
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.10.2026 11:10

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One Step Single Drug Test (Hair)

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: D-L11-ABP01C7RN
Basic UDI-DI: B-L11-ABP01C7RN
Reference: L11-ABP01C7
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.10.2026 11:10

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D-KeraK13X

Kerà K1

Class IIaMDDOn the market

Manufacturer: GIULIANI S.p.A.
Manufacturer SRN: IT-MF-000022648
UDI-DI: D-KeraK13X
Basic UDI-DI: B-KeraK13X
Reference: Kerà K1
EMDN: V9099
EMDN description: VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 13.10.2026 11:10

Manufacturer products View details

Kysense Extreme

Kysense

Class IIIMDDOn the marketImplantableSingle useSterile

Manufacturer: Kylane Laboratoires SA
Manufacturer SRN: CH-MF-000028524
UDI-DI: D-KYS-A310P2
Basic UDI-DI: B-KYS-A310P2
Reference: KYS-A310
EMDN: X0303
EMDN description: SUBSTANCES, COMBINATIONS OF SUBSTANCES, OR ITEMS WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED TO BE USED FOR FACIAL OR OTHER DERMAL OR MUCOUS MEMBRANE FILLING BY SUBCUTANEOUS, SUBMUCOUS OR INTRADERMAL INJECTION OR OTHER INTRODUCTION, BY A PREFILLED MEANS FOR INTRODUCTION, EXCLUDING THOSE FOR TATTOOING – RESORBABLE
First on market country: France
Authorised representative: Sinclair France SAS
Last updated: 13.10.2026 11:10

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Kysense Volume

Kysense

Class IIIMDDOn the marketImplantableSingle useSterile

Manufacturer: Kylane Laboratoires SA
Manufacturer SRN: CH-MF-000028524
UDI-DI: D-KYS-A210NV
Basic UDI-DI: B-KYS-A210NV
Reference: KYS-A210
EMDN: X0303
EMDN description: SUBSTANCES, COMBINATIONS OF SUBSTANCES, OR ITEMS WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED TO BE USED FOR FACIAL OR OTHER DERMAL OR MUCOUS MEMBRANE FILLING BY SUBCUTANEOUS, SUBMUCOUS OR INTRADERMAL INJECTION OR OTHER INTRODUCTION, BY A PREFILLED MEANS FOR INTRODUCTION, EXCLUDING THOSE FOR TATTOOING – RESORBABLE
First on market country: France
Authorised representative: Sinclair France SAS
Last updated: 13.10.2026 11:10

Manufacturer products Authorised representative products Authorised representative actors View details

Kysense Define

Kysense

Class IIIMDDOn the marketImplantableSingle useSterile

Manufacturer: Kylane Laboratoires SA
Manufacturer SRN: CH-MF-000028524
UDI-DI: D-KYS-A110NQ
Basic UDI-DI: B-KYS-A110NQ
Reference: KYS-A110
EMDN: X0303
EMDN description: SUBSTANCES, COMBINATIONS OF SUBSTANCES, OR ITEMS WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED TO BE USED FOR FACIAL OR OTHER DERMAL OR MUCOUS MEMBRANE FILLING BY SUBCUTANEOUS, SUBMUCOUS OR INTRADERMAL INJECTION OR OTHER INTRODUCTION, BY A PREFILLED MEANS FOR INTRODUCTION, EXCLUDING THOSE FOR TATTOOING – RESORBABLE
First on market country: France
Authorised representative: Sinclair France SAS
Last updated: 13.10.2026 11:10

Manufacturer products Authorised representative products Authorised representative actors View details

Kysense Precise

Kysense

Class IIIMDDOn the marketImplantableSingle useSterile

Manufacturer: Kylane Laboratoires SA
Manufacturer SRN: CH-MF-000028524
UDI-DI: D-KYS-A010NK
Basic UDI-DI: B-KYS-A010NK
Reference: KYS-A010
EMDN: X0303
EMDN description: SUBSTANCES, COMBINATIONS OF SUBSTANCES, OR ITEMS WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED TO BE USED FOR FACIAL OR OTHER DERMAL OR MUCOUS MEMBRANE FILLING BY SUBCUTANEOUS, SUBMUCOUS OR INTRADERMAL INJECTION OR OTHER INTRODUCTION, BY A PREFILLED MEANS FOR INTRODUCTION, EXCLUDING THOSE FOR TATTOOING – RESORBABLE
First on market country: France
Authorised representative: Sinclair France SAS
Last updated: 13.10.2026 11:10

Manufacturer products Authorised representative products Authorised representative actors View details

Kratom(KRA) Rapid Test Panel

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: ACtest Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000049724
UDI-DI: D-KRA-4-AT4
Basic UDI-DI: B-KRA-4-AT4
Reference: KRA-4-A
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.10.2026 11:10

Manufacturer products Authorised representative products Authorised representative actors View details

Kratom(KRA) Rapid Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: ACtest Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000049724
UDI-DI: D-KRA-2-ASS
Basic UDI-DI: B-KRA-2-ASS
Reference: KRA-2-A
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.10.2026 11:10

Manufacturer products Authorised representative products Authorised representative actors View details

Kratom(KRA) Rapid Test Dipstick

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: ACtest Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000049724
UDI-DI: D-KRA-1-ASM
Basic UDI-DI: B-KRA-1-ASM
Reference: KRA-1-A
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.10.2026 11:10

Manufacturer products Authorised representative products Authorised representative actors View details

MASTDISCS®AST Cephalothin 30 µg Cartridge discs

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Mast Group Limited
Manufacturer SRN: GB-MF-000025209
UDI-DI: D-KF30CUJ
Basic UDI-DI: B-KF30CUJ
Reference: KF30C
EMDN: W0104080502
EMDN description: IMPREGNATED DISKS, MULTI-DISKS & TABLETS
First on market country: Germany
Authorised representative: Mast Diagnostica GmbH
Last updated: 13.10.2026 11:10

Manufacturer products Authorised representative products Authorised representative actors View details

Ketamine(KET) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: ACtest Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000049724
UDI-DI: D-KET-8-HVE
Basic UDI-DI: B-KET-8-HVE
Reference: KET-8-H
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.10.2026 11:10

Manufacturer products Authorised representative products Authorised representative actors View details

Ketamine (KET)Rapid Test Panel

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: ACtest Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000049724
UDI-DI: D-KET-4-AUC
Basic UDI-DI: B-KET-4-AUC
Reference: KET-4-A
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.10.2026 11:10

Manufacturer products Authorised representative products Authorised representative actors View details

Ketamine (KET)Rapid Test Dipstick

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: ACtest Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000049724
UDI-DI: D-KET-1-ATV
Basic UDI-DI: B-KET-1-ATV
Reference: KET-1-A
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.10.2026 11:10

Manufacturer products Authorised representative products Authorised representative actors View details

MASTDISCS®AST Kanamycin 30 µg Cartridge Discs

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Mast Group Limited
Manufacturer SRN: GB-MF-000025209
UDI-DI: D-K30CG8
Basic UDI-DI: B-K30CG8
Reference: K30C
EMDN: W0104080502
EMDN description: IMPREGNATED DISKS, MULTI-DISKS & TABLETS
First on market country: Germany
Authorised representative: Mast Diagnostica GmbH
Last updated: 13.10.2026 11:10

Manufacturer products Authorised representative products Authorised representative actors View details

Synthetic Marijuana (K2) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: ACtest Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000049724
UDI-DI: D-K2-8-HXP
Basic UDI-DI: B-K2-8-HXP
Reference: K2-8-H
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.10.2026 11:10

Manufacturer products Authorised representative products Authorised representative actors View details