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293 device results listed.

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SCC Squamous Cell Carcinoma Antigen (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-SCC706-AEVY
Basic UDI-DI: B-SCC706-AEVY
Reference: SCC706-AE
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 05:39

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 IgG/IgM Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-SC2GMAb801B9
Basic UDI-DI: B-SC2GMAb801B9
Reference: SC2GMAb801
EMDN: W0105090502
EMDN description: CORONAVIRUS ANTIBODY (AB) - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 05:39

Manufacturer products Authorised representative products Authorised representative actors View details

SAA Test Kit FIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-SAA-D06aB3
Basic UDI-DI: B-SAA-D06aB3
Reference: SAA -D06a
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 15.07.2026 05:34

Manufacturer products Authorised representative products Authorised representative actors View details

SAA Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-SAA-D02aAP
Basic UDI-DI: B-SAA-D02aAP
Reference: SAA-D02a
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 05:34

Manufacturer products Authorised representative products Authorised representative actors View details

Renin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-Renin706-AEQY
Basic UDI-DI: B-Renin706-AEQY
Reference: Renin706-AE10Y, Renin706-AE10N, Renin706-AE20Y, Renin706-AE20N
EMDN: W0102060206
EMDN description: RENINE DIRECT
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 05:33

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19/Influenza A+B/RSV/Adenovirus/MP Antigen Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-RV-G65a28
Basic UDI-DI: B-RV-G65a28
Reference: RV-G65a
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 05:32

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-RV-B55aYV
Basic UDI-DI: B-RV-B55aYV
Reference: RV-B55a
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 05:32

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Syncytial Virus (RSV) Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-RSV-B02bTT
Basic UDI-DI: B-RSV-B02bTT
Reference: RSV-B02b
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 05:32

Manufacturer products Authorised representative products Authorised representative actors View details

RPOG Test Kit FIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-RPOG-C06aL4
Basic UDI-DI: B-RPOG-C06aL4
Reference: RPOG-C06a
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-ROTA-F02aKZ
Basic UDI-DI: B-ROTA-F02aKZ
Reference: ROTA-F02a
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

Rheumatoid Factor Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-RF601WC
Basic UDI-DI: B-RF601WC
Reference: RF6011Y, RF6012Y, RF6013Y, RF6014Y, RF6015Y, RF6011N, RF6012N, RF6013N, RF6014N, RF6015N
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 05:27

Manufacturer products Authorised representative products Authorised representative actors View details

Retinol-Binding Protein Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-RBP602DV
Basic UDI-DI: B-RBP602DV
Reference: RBP6021Y, RBP6022Y, RBP6023Y, RBP6024Y, RBP6025Y, RBP6021N, RBP6022N, RBP6023N, RBP6024N, RBP6025N
EMDN: W0102010306
EMDN description: RETINOL BINDING PROTEIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 05:26

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus/Adenovirus Antigen Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-RAV-F22aKD
Basic UDI-DI: B-RAV-F22aKD
Reference: RAV-F22a
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 15.07.2026 05:25

Manufacturer products Authorised representative products Authorised representative actors View details

Prog Progesterone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-Prog706-AEYF
Basic UDI-DI: B-Prog706-AEYF
Reference: Prog706-AE10Y, Prog706-AE10N, Prog706-AE20Y, Prog706-AE20N
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 05:22

Manufacturer products Authorised representative products Authorised representative actors View details

ProGRP Pro-Gastrin-Releasing Peptide (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-ProGRP706-AEWR
Basic UDI-DI: B-ProGRP706-AEWR
Reference: ProGRP706-AE10Y, ProGRP706-AE10N, ProGRP706-AE20Y, ProGRP706-AE20N
EMDN: W0102030121
EMDN description: PRO-GASTRIN-RELEASING PEPTIDE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 05:22

Manufacturer products Authorised representative products Authorised representative actors View details

PTH Parathyroid Hormone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-PTH706-AE8N
Basic UDI-DI: B-PTH706-AE8N
Reference: PTH706-AE10Y, PTH706-AE10N, PTH706-AE20Y, PTH706-AE20N
EMDN: W0102060312
EMDN description: PARATHYROID HORMONE INTACT
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 17:12

Manufacturer products Authorised representative products Authorised representative actors View details

PRL Prolactin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-PRL706-AE9L
Basic UDI-DI: B-PRL706-AE9L
Reference: PRL706-AE10Y, PRL706-AE10N, PRL706-AE20Y, PRL706-AE20N
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 17:12

Manufacturer products Authorised representative products Authorised representative actors View details

PRL Test Kit FIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-PRL-D06aNS
Basic UDI-DI: B-PRL-D06aNS
Reference: PRL-D06a
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 17:12

Manufacturer products Authorised representative products Authorised representative actors View details

PIVKA-II Protein Induced by Vitamin K Absence or Antagonist-II (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-PIVKA-II706-AEF7
Basic UDI-DI: B-PIVKA-II706-AEF7
Reference: PIVKA-II706-AE10Y, PIVKA-II706-AE10N, PIVKA-II706-AE20Y, PIVKA-II706-AE20N
EMDN: W0102039017
EMDN description: PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 09:45

Manufacturer products Authorised representative products Authorised representative actors View details

PIC Plasmin-α2-Plasmin Inhibitor Complex (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-PIC706-AEXD
Basic UDI-DI: B-PIC706-AEXD
Reference: PIC706-AE10Y, PIC706-AE10N, PIC706-AE20Y, PIC706-AE20N
EMDN: W0103020305
EMDN description: PLASMIN - A2 - ANTIPLASMIN COMPLEX
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 09:45

Manufacturer products Authorised representative products Authorised representative actors View details