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177 device results listed.

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Influenza A/B Ag 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: 69743840305098
Basic UDI-DI: B-69743840305098
Reference: 3020801
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
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

Influenza A/B Antigen Rapid Test（Swab）

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646FLU001KJZP
Basic UDI-DI: B-697424646FLU001KJZP
Reference: FLU-6022
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:06

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Influenza A/B Antigen FIA Test (Swab)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646FLU000FR2CT
Basic UDI-DI: B-697424646FLU000FR2CT
Reference: FLU-6012F
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:06

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LYSUN

FCRAHP-S27(25PCS)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-69717712042779P
Basic UDI-DI: B-69717712042779P
Reference: FCRAHP-S27
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 04:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960APA01PVQB

AFR01-AOG48E; AFR01-AOG96E; AFR01D-AOG48E; AFR01D-AOG96E

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960APA01PVQB
Basic UDI-DI: B-69509960APA01PVQB
Reference: AFR01-AOG48E; AFR01-AOG96E; AFR01D-AOG48E; AFR01D-AOG96E
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960AFAB01L6PY

AFAB01-AOG48E; AFAB01-AOG96E

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960AFAB01L6PY
Basic UDI-DI: B-69509960AFAB01L6PY
Reference: AFAB01-AOG48E; AFAB01-AOG96E
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960AFAB03LAQW

AFAB03-AOG48E; AFAB03-AOG96E; AFAB03D-AOG48E; AFAB03D-AOG96E

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960AFAB03LAQW
Basic UDI-DI: B-69509960AFAB03LAQW
Reference: AFAB03-AOG48E; AFAB03-AOG96E; AFAB03D-AOG48E; AFAB03D-AOG96E
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:52

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/Influenza B (FluA+B) Antigens Rapid Test Kit

Flu Cassette

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757993821RC
Basic UDI-DI: B-693757993821RC
Reference: Flu Cassette
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:49

Manufacturer products Authorised representative products Authorised representative actors View details

Actim® Influenza A&B

32837ETAC

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Actim Oy
Manufacturer SRN: FI-MF-000024323
UDI-DI: D-6430030990424TT
Basic UDI-DI: B-6430030990424TT
Reference: 32837ETAC
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Finland
Authorised representative: -
Last updated: 17.07.2026 03:42

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Actim® Influenza A&B

32836ETAC

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Actim Oy
Manufacturer SRN: FI-MF-000024323
UDI-DI: D-6430030990417TW
Basic UDI-DI: B-6430030990417TW
Reference: 32836ETAC
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Finland
Authorised representative: -
Last updated: 17.07.2026 03:42

Manufacturer products View details

Actim® Influenza A&B

32834ETAC

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Actim Oy
Manufacturer SRN: FI-MF-000024323
UDI-DI: D-6430030990264TV
Basic UDI-DI: B-6430030990264TV
Reference: 32834ETAC
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Finland
Authorised representative: -
Last updated: 17.07.2026 03:42

Manufacturer products View details

Actim® Influenza A&B

32832ETAC

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Actim Oy
Manufacturer SRN: FI-MF-000024323
UDI-DI: D-6430030990240TF
Basic UDI-DI: B-6430030990240TF
Reference: 32832ETAC
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Finland
Authorised representative: -
Last updated: 17.07.2026 03:42

Manufacturer products View details

Influenza A + B Antigen Test (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-5N18C529
Basic UDI-DI: B-5N18C529
Reference: 5N18C5-20-EU, 5N18C5-40-EU
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

Acmex

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Acmex Bio-Technology (Chongqing) Co., Ltd.
Manufacturer SRN: CN-MF-000037745
UDI-DI: 06976232252040
Basic UDI-DI: B-06976232252040
Reference: CA03-41-422P25
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

Aria Influenza A/B Ag Rapid Test

R0187C

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

Manufacturer: CTK Biotech Inc.
Manufacturer SRN: US-MF-000024900
UDI-DI: 00810114461310
Basic UDI-DI: 081011446R0187CER
Reference: R0187C-20T-AR
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Denmark
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

NADAL® Influenza A/B Test

Influenza A/B Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-242915N-10ZT
Basic UDI-DI: B-nvm-242915N-10ZT
Reference: 242915N-10
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:27

Manufacturer products View details

NADAL® Influenza A/B Test

Influenza A/B Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-242015N-10V2
Basic UDI-DI: B-nvm-242015N-10V2
Reference: 242015N-10
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:27

Manufacturer products View details

Bio-Firm

WI-FLU-C82-25

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Wantaifu Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000037582
UDI-DI: D-WI-FLU-C82-25HN
Basic UDI-DI: B-WI-FLU-C82-25HN
Reference: WI-FLU-C82-25
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 13:30

Manufacturer products Authorised representative products Authorised representative actors View details

Bio-Firm

WI-FLU-C82-10

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Wantaifu Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000037582
UDI-DI: D-WI-FLU-C82-10H9
Basic UDI-DI: B-WI-FLU-C82-10H9
Reference: WI-FLU-C82-10
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 13:30

Manufacturer products Authorised representative products Authorised representative actors View details

D-WHATOFLU5J

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: W.H.P.M. Bioresearch & Technology Co., Ltd.
Manufacturer SRN: CN-MF-000003007
UDI-DI: D-WHATOFLU5J
Basic UDI-DI: B-WHATOFLU5J
Reference: WH-AT-OFLU
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:30

Manufacturer products Authorised representative products Authorised representative actors View details