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23 device results listed.

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04099466110633

Serazym® Giardia

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466110633
Basic UDI-DI: B-04099466110633
Reference: E-106
EMDN: W0105050208
EMDN description: GIARDIA LAMBLIA
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:25

Manufacturer products View details

04099466103031

Serazym® Verotoxin 1+2

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466103031
Basic UDI-DI: B-04099466103031
Reference: E-030
EMDN: W0105011502
EMDN description: E. COLI TOXIN
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:25

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04099466102034

Serazym® Rotavirus

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466102034
Basic UDI-DI: B-04099466102034
Reference: E-020
EMDN: W0105040606
EMDN description: ROTAVIRUS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:24

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04099466101822

Serazym® Entamoeba histolytica

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466101822
Basic UDI-DI: B-04099466101822
Reference: E-018
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:24

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04099466101730

Serazym® Adenovirus

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466101730
Basic UDI-DI: B-04099466101730
Reference: E-017
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:24

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04099466400215

Extraction buffer (10x)

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466400215
Basic UDI-DI: 4099466ACS002NY
Reference: ACS-002
EMDN: W0102069009
EMDN description: ELASTASE (PANCREATIC POLYPEPTIDE)
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:26

Manufacturer products View details

04099466400116

Stool Preparation Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466400116
Basic UDI-DI: 4099466ACS001NW
Reference: ACS-001
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:26

Manufacturer products View details

04099466360519

Seramun SpotSight well

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466360519
Basic UDI-DI: 4099466SPWELLAX
Reference: SP-WELL-A
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:26

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04099466360113

Seramun SpotSight plate mono

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466360113
Basic UDI-DI: 4099466SPPLATEEZ
Reference: SP-PLATE-C
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:26

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04099466350015

Seramun SpotSight® scan

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466350015
Basic UDI-DI: 4099466SPSCAN8U
Reference: SP-SCAN-A
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:26

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04099466111425

Serazym® H. pylori 2nd Gen.

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466111425
Basic UDI-DI: B-04099466111425
Reference: E-114
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:43

Manufacturer products View details

04099466110732

Serazym® Clostridium difficile GDH

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466110732
Basic UDI-DI: B-04099466110732
Reference: E-107
EMDN: W0105011801
EMDN description: C.DIFFICILE GDH DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:43

Manufacturer products View details

04099466110510

Serazym® RF IgA/IgG/IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466110510
Basic UDI-DI: B-04099466110510
Reference: E-105
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:43

Manufacturer products View details

04099466110015

Serazym® Nucleo ANA screen plus

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466110015
Basic UDI-DI: B-04099466110015
Reference: E-100
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:43

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04099466109330

Serazym® Campylobacter

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466109330
Basic UDI-DI: B-04099466109330
Reference: E-093
EMDN: W0105011401
EMDN description: CAMPYLOBACTER DIRECT ANTIGEN DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:43

Manufacturer products View details

04099466106131

Serazym® Norovirus

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466106131
Basic UDI-DI: B-04099466106131
Reference: E-061
EMDN: W0105040616
EMDN description: NOROVIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:43

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04099466105813

Serazym® Anti-dsDNA IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466105813
Basic UDI-DI: B-04099466105813
Reference: E-058
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:43

Manufacturer products View details

04099466105417

Serazym® Anti-Cardiolipin-ß2-GP-1 IgG/IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466105417
Basic UDI-DI: B-04099466105417
Reference: E-054
EMDN: W0102100503
EMDN description: ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:43

Manufacturer products View details

04099466104915

Serazym® Anti-Francisella tularensis

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466104915
Basic UDI-DI: B-04099466104915
Reference: E-049
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:43

Manufacturer products View details

04099466104533

Serazym® Astrovirus

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466104533
Basic UDI-DI: B-04099466104533
Reference: E-045
EMDN: W0105040629
EMDN description: ASTROVIRUS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:43

Manufacturer products View details