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91 device results listed.

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++B379DNS1RDSXB

Dengue NS1 Detect™ Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: InBios International, Inc.
Manufacturer SRN: US-MF-000020625
UDI-DI: ++B379DNS1RDSXB
Basic UDI-DI: B-++B379DNS1RDSXB
Reference: DNS1-RD
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Ireland
Authorised representative: AR Experts B.V.
Last updated: 01.08.2026 01:41

Manufacturer products Authorised representative products Authorised representative actors View details

++B379DNS11ZK

DENV Detect™ NS1 ELISA

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: InBios International, Inc.
Manufacturer SRN: US-MF-000020625
UDI-DI: ++B379DNS11ZK
Basic UDI-DI: B-++B379DNS11ZK
Reference: DNS1-1
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Ireland
Authorised representative: AR Experts B.V.
Last updated: 01.08.2026 01:41

Manufacturer products Authorised representative products Authorised representative actors View details

++B379DDMS1ZJ

DENV Detect™ IgM Capture ELISA

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: InBios International, Inc.
Manufacturer SRN: US-MF-000020625
UDI-DI: ++B379DDMS1ZJ
Basic UDI-DI: B-++B379DDMS1ZJ
Reference: DDMS-1
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Ireland
Authorised representative: AR Experts B.V.
Last updated: 01.08.2026 01:41

Manufacturer products Authorised representative products Authorised representative actors View details

++B379DDGS1YL

DENV Detect™ IgG ELISA

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: InBios International, Inc.
Manufacturer SRN: US-MF-000020625
UDI-DI: ++B379DDGS1YL
Basic UDI-DI: B-++B379DDGS1YL
Reference: DDGS-1
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Ireland
Authorised representative: AR Experts B.V.
Last updated: 01.08.2026 01:41

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ Dengue NS1 Ag

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133042212
Basic UDI-DI: 880613300028BR
Reference: CFPC-62
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ Dengue IgG/IgM

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133042137
Basic UDI-DI: 880613300027BP
Reference: CFPC-60
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Hungary
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS Dengue IgG/IgM

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133042090
Basic UDI-DI: 880613300548CQ
Reference: SMFP-41
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors View details

VIDAS® DENGUE NS1 Ag

IVD Class CIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026608217
Basic UDI-DI: 357302BUDI000852U5
Reference: 423077
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

Manufacturer products View details

Dengue IgG, IgM and NS1 Combo Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-DEC-435J7
Basic UDI-DI: B-FI-DEC-435J7
Reference: FI-DEC-435
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 00:49

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-DES-402P8
Basic UDI-DI: B-FI-DES-402P8
Reference: FI-DES-402
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-DEN-402MH
Basic UDI-DI: B-FI-DEN-402MH
Reference: FI-DEN-402
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

VIDAS® Anti-DENGUE IgG

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026608248
Basic UDI-DI: 357302BUDI000627TU
Reference: 423079
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: France
Authorised representative: -
Last updated: 21.07.2026 22:52

Manufacturer products View details

VIDAS® Anti-DENGUE IgM

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026608224
Basic UDI-DI: 357302BUDI000626TS
Reference: 423078
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: France
Authorised representative: -
Last updated: 21.07.2026 22:52

Manufacturer products View details

Dengue NS1 Antigen & IgG/IgM Rapid Test（Whole Blood/Serum/Plasma）

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: 69743840309430
Basic UDI-DI: B-69743840309430
Reference: 3021303
EMDN: W0105040611
EMDN description: DENGUE VIRUS
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

Dengue NS1/IgM/IgG test cassette

Dengue-NS1/IgM/IgG 252102

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757992103PY
Basic UDI-DI: B-693757992103PY
Reference: Dengue-NS1/IgM/IgG 252102
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 17.07.2026 03:49

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 antigen test cassette

Dengue-NS1 252102

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757992102PW
Basic UDI-DI: B-693757992102PW
Reference: Dengue-NS1 252102
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 17.07.2026 03:49

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgM/IgG test cassette

Dengue-IgM/IgG 252102

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757992101PU
Basic UDI-DI: B-693757992101PU
Reference: Dengue-IgM/IgG 252102
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 17.07.2026 03:49

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue Ab and Ag Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)

IDEC-5023

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anhui Formaster Biosci Co., Ltd.
Manufacturer SRN: CN-MF-000002305
UDI-DI: 06974785750556
Basic UDI-DI: B-06974785750556
Reference: IDEC-5023
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.07.2026 19:12

Manufacturer products Authorised representative products Authorised representative actors View details

+ENTIRE586810M

Dengue Virus IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRE586810M
Basic UDI-DI: B-+ENTIRE586810M
Reference: RE58681
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:19

Manufacturer products View details

+ENTIRE586710L

Dengue Virus IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRE586710L
Basic UDI-DI: B-+ENTIRE586710L
Reference: RE58671
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:19

Manufacturer products View details