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Singclean®

Cassette；Panel；Cup

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

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020140416
Basic UDI-DI: 69360201528X
Reference: M90-05-25t
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean®

cassette；panel；cup

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

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020140386
Basic UDI-DI: 69360201118H
Reference: M61-05-25t
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

Carfentanyl Rapid Test

CFYL-U11, CFYL-U23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804817619
Basic UDI-DI: B-06952804817619
Reference: CFYL-U11 CFYL-U23
EMDN: W0102090113
EMDN description: OPIATES
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

Hydromorphone Rapid Test

HMO-U11, HMO-U23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804817558
Basic UDI-DI: B-06952804817558
Reference: HMO-U11 HMO-U23
EMDN: W0102090112
EMDN description: MORPHINES
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

Tilidin Rapid Test

TLD-U11, TLD-U23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804817534
Basic UDI-DI: B-06952804817534
Reference: TLD-U11 TLD-U23
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

Zaleplon Rapid Test

ZAL-U11, ZAL-U23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804817497
Basic UDI-DI: B-06952804817497
Reference: ZAL-U11 ZAL-U23
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

7-Amino clonazepam Rapid Test

7-ACL-U11, 7-ACL-U23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804817428
Basic UDI-DI: B-06952804817428
Reference: 7-ACL-U11 7-ACL-U23
EMDN: W0102090104
EMDN description: BENZODIAZEPINES
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

Clonazepam Rapid Test

CLO-U11, CLO-U23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804817404
Basic UDI-DI: B-06952804817404
Reference: CLO-U11 CLO-U23
EMDN: W0102090104
EMDN description: BENZODIAZEPINES
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

6-Monoacetylmorphine

MAM-U11, MAM-U23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804817329
Basic UDI-DI: B-06952804817329
Reference: MAM-U11 MAM-U23
EMDN: W0102090112
EMDN description: MORPHINES
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

Fentanyl Rapid Test

FYL-U11, FYL-U23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804817244
Basic UDI-DI: B-06952804817244
Reference: FYL-U11 FYL-U23
EMDN: W0102090113
EMDN description: OPIATES
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:30

Manufacturer products Authorised representative products Authorised representative actors View details

Buprenorphine Rapid Test

BUP-U11, BUP-U23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804817206
Basic UDI-DI: B-06952804817206
Reference: BUP-U11 BUP-U23
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:30

Manufacturer products Authorised representative products Authorised representative actors View details

Propoxyphene Rapid Test

PPX-U11, PPX-U23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804817183
Basic UDI-DI: B-06952804817183
Reference: PPX-U11, PPX-U23
EMDN: W0102090115
EMDN description: PROPOXYPHENE
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:30

Manufacturer products Authorised representative products Authorised representative actors View details

Methaqualone Rapid Test

MQL-U11, MQL-U23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804817169
Basic UDI-DI: B-06952804817169
Reference: MQL-U11 MQL-U23
EMDN: W0102090111
EMDN description: METHAQUALONE
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:30

Manufacturer products Authorised representative products Authorised representative actors View details

Meperidine Rapid Test

MPRD-U11, MPRD-U23

IVD generalIVDDOn the marketKitReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804817107
Basic UDI-DI: B-06952804817107
Reference: MPRD-U11, MPRD-U23
EMDN: W0102090113
EMDN description: OPIATES
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:30

Manufacturer products Authorised representative products Authorised representative actors View details

Cotinine Rapid Test

COT-U11, COT-U23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804817022
Basic UDI-DI: B-06952804817022
Reference: COT-U11, COT-U23
EMDN: W0102090108
EMDN description: COTININE
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:30

Manufacturer products Authorised representative products Authorised representative actors View details

Pregabalin Rapid Test

PGB-U11 PGB-U23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804814571
Basic UDI-DI: B-06952804814571
Reference: PGB-U11 PGB-U23
EMDN: W0102090112
EMDN description: MORPHINES
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Tramadol Rapid Test

TML-U11 TML-U23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804814496
Basic UDI-DI: B-06952804814496
Reference: TML-U11 TML-U23
EMDN: W0102090107
EMDN description: CODEINE
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Morphine Rapid Test

MOR-U11, MOR-U23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804814335
Basic UDI-DI: B-06952804814335
Reference: MOR-U11, MOR-U23
EMDN: W0102090112
EMDN description: MORPHINES
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Fentanyl FIA

FYL-U23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804803681
Basic UDI-DI: B-06952804803681
Reference: FYL-U23F3
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:25

Manufacturer products Authorised representative products Authorised representative actors View details

MDMA FIA

MDMA-H23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804803643
Basic UDI-DI: B-06952804803643
Reference: MDMA-H23F3
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:25

Manufacturer products Authorised representative products Authorised representative actors View details