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CRP/SAA Rapid Quantitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260212125
Basic UDI-DI: B-06933260212125
Reference: BT2304
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Ag + Adenovirus Resp. Ag COMBO rapid test cassette (Swab) positive controls included Test rapid determinare RSV Ag + Adenovirus Resp. Ag COMBO, caseta (Swab) cu controale pozitive incluse

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingSingle use

Manufacturer: VitroBioChem SRL
Manufacturer SRN: RO-MF-000010877
UDI-DI: 05944759080119
Basic UDI-DI: 5944759080VTRSVA25STNB68G
Reference: VT-RSVA-25
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:25

Manufacturer products View details

HAV IgM Rapid Test Cassette (Serum/ Plasma) Test Rapid HAV IgM (ser/plasma), caseta

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingSingle use

Manufacturer: VitroBioChem SRL
Manufacturer SRN: RO-MF-000010877
UDI-DI: 05944759080072
Basic UDI-DI: 5944759080VTHAVM25SPCB6JW
Reference: VT-HAVM-25
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:25

Manufacturer products View details

Multi-Line 12 Drugs Rapid Test Cassette (urine) TEST RAPID MULTIDROG 12 PARAMETRI (DIN URINA) CASETA

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use

Manufacturer: VitroBioChem SRL
Manufacturer SRN: RO-MF-000010877
UDI-DI: 05944759080041
Basic UDI-DI: 5944759080VTMLD1225USB6V3
Reference: VT-MLD12-25
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:25

Manufacturer products View details

Multi-Line 18 Drugs (urine) Test Cassette TEST RAPID MULTIDROG 18 PARAMETRI (DIN URINA) CASETA

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use

Manufacturer: VitroBioChem SRL
Manufacturer SRN: RO-MF-000010877
UDI-DI: 05944759080027
Basic UDI-DI: 5944759080VTMLD1825USB6Y9
Reference: VT-MLD18-25
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:25

Manufacturer products View details

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IVD rapid tests

IVD Class BIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: S.C. CAMP MEDICA DISTRIBUTION SRL
Manufacturer SRN: RO-MF-000002110
UDI-DI: 05944759012974
Basic UDI-DI: 5944759012SEENOWDMIVD00EC
Reference: SN1.1
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:18

Manufacturer products View details

Ultrarani test za trudnoću

CB14

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

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 08001841567471
Basic UDI-DI: 4084500CB14QT
Reference: 08001841567471
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Croatia
Authorised representative: MDSS GmbH
Last updated: 30.07.2026 23:29

Manufacturer products Authorised representative products Authorised representative actors View details

Test shtatzënie me zbulim të shpejtë

CB11/CB11A

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

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 04084500759572
Basic UDI-DI: 4084500CB11/CB11AUR
Reference: 04084500759572
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Croatia
Authorised representative: MDSS GmbH
Last updated: 30.07.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

Pregnancy testing kit-(7.0mm)

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: Nantong Diagnos Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000041526
UDI-DI: 06934592100081
Basic UDI-DI: B-06934592100081
Reference: AE68
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: France
Authorised representative: Kingsmead Service B.V.
Last updated: 30.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

VIDAS® Protein C

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064174
Basic UDI-DI: 357302BUDI000072T3
Reference: 30115
EMDN: W0102160601
EMDN description: C-REACTIVE PROTEIN - RT & POC
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:47

Manufacturer products View details

D-TFO-602XJ

FOB Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: CITEST DIAGNOSTICS INC
Manufacturer SRN: CA-MF-000022516
UDI-DI: D-TFO-602XJ
Basic UDI-DI: B-TFO-602XJ
Reference: TFO-602
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.07.2026 06:49

Manufacturer products Authorised representative products Authorised representative actors View details

D-DTH-102RJ

Marijuana (THC50) Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: CITEST DIAGNOSTICS INC
Manufacturer SRN: CA-MF-000022516
UDI-DI: D-DTH-102RJ
Basic UDI-DI: B-DTH-102RJ
Reference: DTH-102
EMDN: W0102160505
EMDN description: CANNABINOIDS - RT & POC
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

D-DOP-102S9

Opiates (OPI) Rapid Test Cassette (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: CITEST DIAGNOSTICS INC
Manufacturer SRN: CA-MF-000022516
UDI-DI: D-DOP-102S9
Basic UDI-DI: B-DOP-102S9
Reference: DOP-102
EMDN: W0102160508
EMDN description: OPIATES - RT & POC
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

D-DOA-155(CT)2W

Multi-Drug 5 Drugs Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: CITEST DIAGNOSTICS INC
Manufacturer SRN: CA-MF-000022516
UDI-DI: D-DOA-155(CT)2W
Basic UDI-DI: B-DOA-155(CT)2W
Reference: DOA-155(CT)
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

D-DOA-1105(CT)QK

Multi-Drug 10 Drugs Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: CITEST DIAGNOSTICS INC
Manufacturer SRN: CA-MF-000022516
UDI-DI: D-DOA-1105(CT)QK
Basic UDI-DI: B-DOA-1105(CT)QK
Reference: DOA-1105(CT)
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

D-DME-102MN

Methamphetamine (MET) Rapid Test Cassette (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: CITEST DIAGNOSTICS INC
Manufacturer SRN: CA-MF-000022516
UDI-DI: D-DME-102MN
Basic UDI-DI: B-DME-102MN
Reference: DME-102
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

Kratom Rapid Test Cassette (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-DKRA-R102acroLJ
Basic UDI-DI: B-DKRA-R102acroLJ
Reference: DKRA-R102
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

D-DKE-102LU

Ketamine (KET) Rapid Test Cassette (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: CITEST DIAGNOSTICS INC
Manufacturer SRN: CA-MF-000022516
UDI-DI: D-DKE-102LU
Basic UDI-DI: B-DKE-102LU
Reference: DKE-102
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

GAB Rapid Test Cassette (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-DGAB-R102acroY9
Basic UDI-DI: B-DGAB-R102acroY9
Reference: DGAB-R102
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

D-DFY-102RP

Fentanyl (FYL) Rapid Test Cassette (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: CITEST DIAGNOSTICS INC
Manufacturer SRN: CA-MF-000022516
UDI-DI: D-DFY-102RP
Basic UDI-DI: B-DFY-102RP
Reference: DFY-102
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details