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374 device results listed.

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GastroPanel® quick test NT

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587602417
Basic UDI-DI: B-06419587602417
Reference: 602410
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:54

Manufacturer products View details

GastroPanel® quick test

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587023205
Basic UDI-DI: B-06419587023205
Reference: 602320
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: -
Authorised representative: -
Last updated: 03.08.2026 03:52

Manufacturer products View details

CORMAY TPHA 100

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514662593
Basic UDI-DI: B-05907514662593
Reference: 6-259
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:09

Manufacturer products View details

CORMAY RPR Carbon 500

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514662562
Basic UDI-DI: B-05907514662562
Reference: 6-256
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:09

Manufacturer products View details

DyonCalpro double (50/200)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: DYONMED SA
Manufacturer SRN: GR-MF-000033588
UDI-DI: 05200251200050
Basic UDI-DI: B-05200251200050
Reference: DNCT101dd
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Greece
Authorised representative: -
Last updated: 02.08.2026 18:47

Manufacturer products View details

xPOC Cartridge

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingReagent

Manufacturer: GENSPEED Biotech
Manufacturer SRN: AT-MF-000013008
UDI-DI: 09120131770038
Basic UDI-DI: 912013177xPOCCartS4
Reference: GSPC2
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:42

Manufacturer products View details

Vitamin D xPOC

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: GENSPEED Biotech
Manufacturer SRN: AT-MF-000013008
UDI-DI: 09120131770021
Basic UDI-DI: 912013177VitaminD3CJ
Reference: IATK215
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:42

Manufacturer products View details

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

Mivolis cöliákia gyorsteszt

Mivolis Schnelltest Zöliakie ( SK/HU/RO/HR)

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: NanoRepro AG
Manufacturer SRN: DE-MF-000023735
UDI-DI: D-400252M8
Basic UDI-DI: B-400252M8
Reference: 400252
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 22.07.2026 22:54

Manufacturer products View details

Barza AmnioTest

Barza Amniotest

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-710088P5
Basic UDI-DI: B-710088P5
Reference: 710088
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Romania
Authorised representative: QbD RepS BV
Last updated: 17.07.2026 04:29

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin FIA 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-697424646PCT000FSCF8
Basic UDI-DI: B-697424646PCT000FSCF8
Reference: PCT-4012F
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:14

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin FIA Test (Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646PCT001FSFFM
Basic UDI-DI: B-697424646PCT001FSFFM
Reference: PCT-3012F
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:14

Manufacturer products Authorised representative products Authorised representative actors View details

Interleukin-6 FIA Test (Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-6974246466IL001FCUUB
Basic UDI-DI: B-6974246466IL001FCUUB
Reference: 6IL-3012F
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:01

Manufacturer products Authorised representative products Authorised representative actors View details

Interleukin-6 FIA 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-6974246466IL000FCRTW
Basic UDI-DI: B-6974246466IL000FCRTW
Reference: 6IL-4012F
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:01

Manufacturer products Authorised representative products Authorised representative actors View details

Actim® Partus 1ngeni Test

31931RETAL

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Actim Oy
Manufacturer SRN: FI-MF-000024323
UDI-DI: D-6430030990585UL
Basic UDI-DI: B-6430030990585UL
Reference: 31931RETAL
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 17.07.2026 03:43

Manufacturer products View details

Actim® PROM 1ngeni Test

30832RETAL

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Actim Oy
Manufacturer SRN: FI-MF-000024323
UDI-DI: D-6430030990561U6
Basic UDI-DI: B-6430030990561U6
Reference: 30832RETAL
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 17.07.2026 03:43

Manufacturer products View details

Actim® Partus Test

31931ETAL

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Actim Oy
Manufacturer SRN: FI-MF-000024323
UDI-DI: D-6430030990530TT
Basic UDI-DI: B-6430030990530TT
Reference: 31931ETAL
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 17.07.2026 03:43

Manufacturer products View details

Actim® PROM 1ngeni

30831RETAC

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Actim Oy
Manufacturer SRN: FI-MF-000024323
UDI-DI: D-6430030990554U9
Basic UDI-DI: B-6430030990554U9
Reference: 30831RETAC
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 17.07.2026 03:43

Manufacturer products View details