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08588007926018

GN 24

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: Diagnostics s.r.o.
Manufacturer SRN: SK-MF-000038255
UDI-DI: 08588007926018
Basic UDI-DI: B-08588007926018
Reference: 1001
EMDN: W0104080201
EMDN description: GRAM NEGATIVE - MANUAL IDENTIFICATION
First on market country: Slovakia
Authorised representative: -
Last updated: 08.07.2026 01:23

Manufacturer products View details

VIUICK

Diagnostic Kit for Ureaplasma Urealyticum DNA (Real-Time PCR Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Viuick Biotechnology Co.,LTD.
Manufacturer SRN: CN-MF-000017369
UDI-DI: 06975400320048
Basic UDI-DI: B-06975400320048
Reference: 48 Tests/Kit
EMDN: W0104080207
EMDN description: MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:30

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma Pheumonia IgG (MP IgG) Detection Kit(CLIA)

50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674893210
Basic UDI-DI: B-06974674893210
Reference: 18-02-0193
EMDN: W0104080207
EMDN description: MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:18

Manufacturer products Authorised representative products Authorised representative actors View details

MP IgM FIA Kit

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892404
Basic UDI-DI: B-06974674892404
Reference: 18-02-0070
EMDN: W0104080207
EMDN description: MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:14

Manufacturer products Authorised representative products Authorised representative actors View details

MP IgG FIA Kit

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892398
Basic UDI-DI: B-06974674892398
Reference: MP IgG FIA Kit
EMDN: W0104080207
EMDN description: MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:14

Manufacturer products Authorised representative products Authorised representative actors View details

ZELEŇ MALACHITOVÁ indikátor

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingReagentSingle use

Manufacturer: Ing. Petr Švec - PENTA s.r.o.
Manufacturer SRN: CZ-MF-000035988
UDI-DI: 08595142262901
Basic UDI-DI: 85951422496209T
Reference: 28500-30010
EMDN: W0104080299
EMDN description: MANUAL IDENTIFICATION - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:55

Manufacturer products View details

LÖFFLER ROZTOK

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingProfessional testingReagentSingle use

Manufacturer: Ing. Petr Švec - PENTA s.r.o.
Manufacturer SRN: CZ-MF-000035988
UDI-DI: 08595142257204
Basic UDI-DI: 85951422209307Q
Reference: 20930-11000
EMDN: W0104080299
EMDN description: MANUAL IDENTIFICATION - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:55

Manufacturer products View details

PANDY ROZTOK

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentReagentSingle use

Manufacturer: Ing. Petr Švec - PENTA s.r.o.
Manufacturer SRN: CZ-MF-000035988
UDI-DI: 08595142250601
Basic UDI-DI: 85951422235407U
Reference: 23540-11000
EMDN: W0104080299
EMDN description: MANUAL IDENTIFICATION - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:55

Manufacturer products View details

GRAM IV roztok

GRAM IV ROZTOK

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingReagentSingle use

Manufacturer: Ing. Petr Švec - PENTA s.r.o.
Manufacturer SRN: CZ-MF-000035988
UDI-DI: 08595142250007
Basic UDI-DI: 85951422146307S
Reference: 14630
EMDN: W0104080201
EMDN description: GRAM NEGATIVE - MANUAL IDENTIFICATION
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:55

Manufacturer products View details

GRAM II roztok

GRAM II ROZTOK

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingProfessional testingReagentSingle use

Manufacturer: Ing. Petr Švec - PENTA s.r.o.
Manufacturer SRN: CZ-MF-000035988
UDI-DI: 08595142249803
Basic UDI-DI: 85951422146107L
Reference: 14610
EMDN: W0104080203
EMDN description: GRAM POSITIVE - MANUAL IDENTIFICATION
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:55

Manufacturer products View details

GRAM I roztok

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingProfessional testingReagentSingle use

Manufacturer: Ing. Petr Švec - PENTA s.r.o.
Manufacturer SRN: CZ-MF-000035988
UDI-DI: 08595142249704
Basic UDI-DI: 85951422146007H
Reference: 14600
EMDN: W0104080203
EMDN description: GRAM POSITIVE - MANUAL IDENTIFICATION
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:55

Manufacturer products View details

ACETONALKOHOL

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingProfessional testingReagentSingle use

Manufacturer: Ing. Petr Švec - PENTA s.r.o.
Manufacturer SRN: CZ-MF-000035988
UDI-DI: 08595142248059
Basic UDI-DI: 85951422413107H
Reference: 41310
EMDN: W0104080203
EMDN description: GRAM POSITIVE - MANUAL IDENTIFICATION
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:55

Manufacturer products View details

ZKOUMADLO ZIEHL-NEELSEN II

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingProfessional testingReagentSingle use

Manufacturer: Ing. Petr Švec - PENTA s.r.o.
Manufacturer SRN: CZ-MF-000035988
UDI-DI: 08595142247977
Basic UDI-DI: 85951422412507Q
Reference: 41250
EMDN: W0104080299
EMDN description: MANUAL IDENTIFICATION - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:55

Manufacturer products View details

PYR 50 TEST KIT

PYR TEST KIT

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Remel, Inc.
Manufacturer SRN: US-MF-000044686
UDI-DI: 00848838028892
Basic UDI-DI: 8488380PYRDiskXB
Reference: R30854301
EMDN: W0104080208
EMDN description: SINGLE TESTS (DISCS, STRIPS, DROPPERS...)
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 03.07.2026 15:23

Manufacturer products Authorised representative products Authorised representative actors View details

LAP 50 TEST KIT

LAP TEST KIT

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Remel, Inc.
Manufacturer SRN: US-MF-000044686
UDI-DI: 00848838028625
Basic UDI-DI: 8488380LAPDiskJR
Reference: R30168501
EMDN: W0104080208
EMDN description: SINGLE TESTS (DISCS, STRIPS, DROPPERS...)
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 03.07.2026 15:23

Manufacturer products Authorised representative products Authorised representative actors View details

NITROCEFIN DISK

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Remel, Inc.
Manufacturer SRN: US-MF-000044686
UDI-DI: 00848838023088
Basic UDI-DI: 8488380NitrocefinDisk47
Reference: R211667
EMDN: W0104080208
EMDN description: SINGLE TESTS (DISCS, STRIPS, DROPPERS...)
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 03.07.2026 15:22

Manufacturer products Authorised representative products Authorised representative actors View details

MICRODASE DISK

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Remel, Inc.
Manufacturer SRN: US-MF-000044686
UDI-DI: 00848838022746
Basic UDI-DI: 8488380MicrodaseDiskAG
Reference: R21132
EMDN: W0104080208
EMDN description: SINGLE TESTS (DISCS, STRIPS, DROPPERS...)
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 03.07.2026 15:22

Manufacturer products Authorised representative products Authorised representative actors View details

CATARRHALIS TEST DISK

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Remel, Inc.
Manufacturer SRN: US-MF-000044686
UDI-DI: 00848838022593
Basic UDI-DI: 8488380CatarrhalisDiskQM
Reference: R21121
EMDN: W0104080208
EMDN description: SINGLE TESTS (DISCS, STRIPS, DROPPERS...)
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 03.07.2026 15:22

Manufacturer products Authorised representative products Authorised representative actors View details

BACTICARD NEISSERIA

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Remel, Inc.
Manufacturer SRN: US-MF-000044686
UDI-DI: 00848838022470
Basic UDI-DI: 8488380BctCrdNeisseriaBV
Reference: R21110
EMDN: W0104080201
EMDN description: GRAM NEGATIVE - MANUAL IDENTIFICATION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 03.07.2026 15:22

Manufacturer products Authorised representative products Authorised representative actors View details

BACTICARD E. COLI

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Remel, Inc.
Manufacturer SRN: US-MF-000044686
UDI-DI: 00848838022456
Basic UDI-DI: 8488380BctCrdEcoliHQ
Reference: R21108
EMDN: W0104080201
EMDN description: GRAM NEGATIVE - MANUAL IDENTIFICATION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 03.07.2026 15:22

Manufacturer products Authorised representative products Authorised representative actors View details