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One Step COC Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840308204
Basic UDI-DI: B-69743840308204
Reference: 3030601
EMDN: W0102090106
EMDN description: COCAINE + COCAINE METABOLITES
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Morphine Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840303568
Basic UDI-DI: B-69743840303568
Reference: 3031601
EMDN: W0102090112
EMDN description: MORPHINES
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:10

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Marihuana Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840303490
Basic UDI-DI: B-69743840303490
Reference: 3031201
EMDN: W0102090105
EMDN description: CANNABINOIDS
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:10

Manufacturer products Authorised representative products Authorised representative actors View details

LYSUN

COT-U21（25PCS）

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-69717712016969S
Basic UDI-DI: B-69717712016969S
Reference: COT-U21(25PCS)
EMDN: W0102090108
EMDN description: COTININE
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 03:59

Manufacturer products Authorised representative products Authorised representative actors View details

LYSUN

MQL-U11(25PCS)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-69717712016589J
Basic UDI-DI: B-69717712016589J
Reference: MQL-U11(25PCS)
EMDN: W0102090111
EMDN description: METHAQUALONE
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 03:59

Manufacturer products Authorised representative products Authorised representative actors View details

LYSUN

OXY-U21（25PCS）

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-697177120158096
Basic UDI-DI: B-697177120158096
Reference: OXY-U21（25PCS）
EMDN: W0102090123
EMDN description: OXYCODINE
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 03:58

Manufacturer products Authorised representative products Authorised representative actors View details

LYSUN

MOP-U21(25PCS)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-69717712015118K
Basic UDI-DI: B-69717712015118K
Reference: MOP-U21(25PCS)
EMDN: W0102090112
EMDN description: MORPHINES
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 03:58

Manufacturer products Authorised representative products Authorised representative actors View details

LYSUN

PPX-U11（25PCS）

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-697177120136896
Basic UDI-DI: B-697177120136896
Reference: PPX-U11（25PCS）
EMDN: W0102090115
EMDN description: PROPOXYPHENE
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 03:58

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Oxycodone Assay

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414027937
Basic UDI-DI: 0405686901153V4
Reference: 10720816
EMDN: W0102090123
EMDN description: OXYCODINE
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

ARK EDDP Assay

5051-0001-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003841
Basic UDI-DI: 0858724003EDDP0515Z
Reference: 5051-0001-00
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:43

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Tramadol Assay

5040-0001-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003773
Basic UDI-DI: 0858724003TRA0406V
Reference: 5040-0001-00
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:43

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Methylphenidate Metabolite Assay

5042-0001-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003544
Basic UDI-DI: 0858724003MHP0423Z
Reference: 5042-0001-00
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:43

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Ethyl Glucuronide II Assay

5077-0001-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101032084
Basic UDI-DI: 0858724003ETG0773H
Reference: 5077-0001-00
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:38

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Ketamine II Assay

5083-0001-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101031599
Basic UDI-DI: 0858724003KET0833G
Reference: 5083-0001-00
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:38

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Zopiclone Assay

5043-0001-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101031308
Basic UDI-DI: 0858724003ZPC04399
Reference: 5043-0001-00
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:38

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Fentanyl II Assay

5069-0001-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030561
Basic UDI-DI: 0858724003FEN069Y8
Reference: 5069-0001-00
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:38

Manufacturer products Authorised representative products Authorised representative actors View details

ARK HS Benzodiazepine II Assay

5073-0001-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030479
Basic UDI-DI: 0858724003BZD0733F
Reference: 5073-0001-00
EMDN: W0102090104
EMDN description: BENZODIAZEPINES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:38

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Pregabalin II Assay

5059-0001-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030448
Basic UDI-DI: 0858724003PGB0592C
Reference: 5059-0001-00
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:38

Manufacturer products Authorised representative products Authorised representative actors View details

ARK AB-PINACA Assay

5055-0001-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030349
Basic UDI-DI: 0858724003ABP055V9
Reference: 5055-0001-00
EMDN: W0102090105
EMDN description: CANNABINOIDS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:38

Manufacturer products Authorised representative products Authorised representative actors View details

ARK UR-144/JWH-018 Assay

5054-0001-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030240
Basic UDI-DI: 0858724003URJ0549L
Reference: 5054-0001-00
EMDN: W0102090105
EMDN description: CANNABINOIDS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:38

Manufacturer products Authorised representative products Authorised representative actors View details