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

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646DEN001EQRT
Basic UDI-DI: B-697424646DEN001EQRT
Reference: DEN-4032/DEN-3032
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM Rapid Test Kit(Whole Blood/serum/plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646DEN000EQRN
Basic UDI-DI: B-697424646DEN000EQRN
Reference: DEN-3022
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I Rapid Test Kit(Whole Blood/serum/plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CTNI000U8JT
Basic UDI-DI: B-697424646CTNI000U8JT
Reference: CTNI-4012
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:04

Manufacturer products Authorised representative products Authorised representative actors View details

Chikungunya IgG/IgM Rapid Test(Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CHIK001N596
Basic UDI-DI: B-697424646CHIK001N596
Reference: CHIK-3022
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:03

Manufacturer products Authorised representative products Authorised representative actors View details

Chikungunya IgG/IgM Rapid Test(Whole Blood/Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646CHIK000N38V
Basic UDI-DI: B-697424646CHIK000N38V
Reference: CHIK-4022
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:03

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Antigen Rapid Test (Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646ADV001EYT9
Basic UDI-DI: B-697424646ADV001EYT9
Reference: ADV-5011/ADV-5012
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Rapid Test (Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646ADV000EWSY
Basic UDI-DI: B-697424646ADV000EWSY
Reference: ADV-5011/ADV-5012
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

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

LYSUN

DEG-P21（25PCS）

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-69717712009349C
Basic UDI-DI: B-69717712009349C
Reference: DEG-W21（25PCS）
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 03:57

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

D-69384449ROTA3Y

strip, cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Equinox Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000018901
UDI-DI: D-69384449ROTA3Y
Basic UDI-DI: B-69384449ROTA3Y
Reference: RH-ROTA
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 17.07.2026 03:51

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

Manufacturer products View details

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

Respiratory Syncytial Virus Antigen Test (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-5N26C526
Basic UDI-DI: B-5N26C526
Reference: 5N26C5-20-EU, 5N26C5-40-EU
EMDN: W0105099002
EMDN description: RSV - 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

Dengue NS1 Antigen Test (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-5N23C1ZC
Basic UDI-DI: B-5N23C1ZC
Reference: 5N23C1-25-EU, 5N23C1-50-EU
EMDN: W0105099007
EMDN description: DENGUE - 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