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iFlash-Mycoplasma pn. IgM

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912715764
Basic UDI-DI: 692591270094HL
Reference: C88004M-L
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Mycoplasma pn. IgG

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912715757
Basic UDI-DI: 692591270093HJ
Reference: C88003G-L
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:30

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iFlash-Anti-TP

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912715603
Basic UDI-DI: 692591270114GZ
Reference: C88049-L
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:30

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Clostridium difficile GDH+Toxin A+Toxin B Combo, Rapid Test Cassette (Feces), positive controls included Test rapid determinare Clostridium difficile GDH+Toxina A+Toxina B, caseta COMBO (materii fecale) cu controale pozitive swab incluse

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingSingle use

Manufacturer: VitroBioChem SRL
Manufacturer SRN: RO-MF-000010877
UDI-DI: 05944759080126
Basic UDI-DI: 5944759080VTCDABGDH25B6X8
Reference: VT-CDABGDH-25
EMDN: W0105011803
EMDN description: C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:25

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TEST RAPID H. PYLORI ANTIGEN CASETA(SCAUN)

HELICOBACTER PYLORI AG RAPID TEST CASSETTE (FECES)

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: VitroBioChem SRL
Manufacturer SRN: RO-MF-000010877
UDI-DI: 05944759080003
Basic UDI-DI: 5944759080VTHPG25STO1B6H5
Reference: VT-HPG-25
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:25

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PreventID® H. pylori

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598015456
Basic UDI-DI: B-04050598015456
Reference: KST18116GP.05
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

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STREPTOCOCCAL GROUPING KIT

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384013036
Basic UDI-DI: 5032384StrepGroupingKitQQ
Reference: DR0585A
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

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STREPTOCOCCAL GROUPING REAGENT A

OXOID STREPTOCOCCAL GROUPING REAGENTS

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384013043
Basic UDI-DI: 5032384StrepGroupLatexPP
Reference: DR0586G
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

E. COLI O157 TEST KIT

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384013142
Basic UDI-DI: 5032384Ecoli5W
Reference: DR0620M
EMDN: W0105011501
EMDN description: E. COLI DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

LEGIONELLA LATEX TEST

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384013197
Basic UDI-DI: 5032384LegionAgglutKitB5
Reference: DR0800M
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

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LEGIONELLA PNEUMO GROUP 1

LEGIONELLA LATEX TEST

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384013203
Basic UDI-DI: 5032384LegionAgglutLtxCK
Reference: DR0801M
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

LEGIONELLA PNEUMO GROUPS 2-14

IVD Class BNot specifiedOn the market

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384013210
Basic UDI-DI: 5032384LegionAgglutLtxCK
Reference: DR0802M
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

LEGIONELLA SPECIES TEST KIT

IVD Class BNot specifiedOn the market

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384013227
Basic UDI-DI: 5032384LegionAgglutLtxCK
Reference: DR0803M
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

DRYSPOT E. COLI O157

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384034420
Basic UDI-DI: 5032384DrySpotEcoliJZ
Reference: DR0120M
EMDN: W0105011501
EMDN description: E. COLI DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

DRYSPOT LEGIONELLA PNEUMOPHILA 1

DRYSPOT LEGIONELLA

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384060535
Basic UDI-DI: 5032384DSLegionellaXZ
Reference: DR0200M
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

DRYSPOT LEGIONELLA PNEUMOPHILA 2-14

IVD Class BNot specifiedOn the market

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384060542
Basic UDI-DI: 5032384DSLegionellaXZ
Reference: DR0210M
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

DRYSPOT LEGIONELLA SPECIES

IVD Class BNot specifiedOn the market

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384061365
Basic UDI-DI: 5032384DSLegionellaXZ
Reference: DR0220M
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

OXOID SALMONELLA

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384127757
Basic UDI-DI: 5032384OxoidSalmonellaDD
Reference: DR1108A
EMDN: W0105011001
EMDN description: SALMONELLA ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

RAPID HP STAR LATERAL FLOW KIT

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384171736
Basic UDI-DI: 5032384RapIDHpStARE3
Reference: K671411-2
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

AMPLIFIED IDEIA HP STAR KIT

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384171811
Basic UDI-DI: 5032384IdeiaHpStarZ6
Reference: K663011-2
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details