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Milieu à l'arginine M42

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Eurobio Scientific
Manufacturer SRN: FR-MF-000011745
UDI-DI: D-PL20032N8
Basic UDI-DI: B-PL20032N8
Reference: PL20032
EMDN: W0104080207
EMDN description: MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)
First on market country: France
Authorised representative: -
Last updated: 14.07.2026 09:45

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Milieu à l'urée U9 pour mycoplasmes urogénitaux

Milieu à l'urée U9 pour Mycoplasmes urogénitaux

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Eurobio Scientific
Manufacturer SRN: FR-MF-000011745
UDI-DI: D-PL20022N5
Basic UDI-DI: B-PL20022N5
Reference: PL20022
EMDN: W0104080207
EMDN description: MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)
First on market country: France
Authorised representative: -
Last updated: 14.07.2026 09:45

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ONLY MYCO TREATMENT WELL D-ONE

MS01397

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-MS01397QC
Basic UDI-DI: B-MS01397QC
Reference: MS01398
EMDN: W0104080207
EMDN description: MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 05:14

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MYCO WELL D-ONE SIX

MS01379

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-MS01379QA
Basic UDI-DI: B-MS01379QA
Reference: MS01379
EMDN: W0104080207
EMDN description: MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 05:13

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MYCO PNEUMO ONE

MS01352

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-MS01352PN
Basic UDI-DI: B-MS01352PN
Reference: MS01352
EMDN: W0104080207
EMDN description: MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 05:13

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MYCO WELL D-ONE AST

MS01347

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-MS01347PV
Basic UDI-DI: B-MS01347PV
Reference: MS01347
EMDN: W0104080207
EMDN description: MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 05:13

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MYCO WELL D‐ONE® 32 FIRST COMPLETE KIT

MS01333

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-MS01333PJ
Basic UDI-DI: B-MS01333PJ
Reference: MS01333
EMDN: W0104080207
EMDN description: MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 05:13

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ENTERO WELL D‐ONE

MS01331

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-MS01331PE
Basic UDI-DI: B-MS01331PE
Reference: MS01331
EMDN: W0104080201
EMDN description: GRAM NEGATIVE - MANUAL IDENTIFICATION
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 05:13

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MYCO WELL D-ONE FIRST

MS01327

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-MS01327PP
Basic UDI-DI: B-MS01327PP
Reference: MS01327
EMDN: W0104080207
EMDN description: MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 05:13

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MYCO WELL D‐ONE 32 COMPLETE KIT

MS01321

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-MS01321PB
Basic UDI-DI: B-MS01321PB
Reference: MS01321
EMDN: W0104080207
EMDN description: MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 05:13

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NEW MYCO WELL D-ONE 24

MS01312

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-MS01312PA
Basic UDI-DI: B-MS01312PA
Reference: MS01312
EMDN: W0104080207
EMDN description: MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 05:13

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ARI WELL D-ONE

MS01293

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-MS01293PX
Basic UDI-DI: B-MS01293PX
Reference: MS01293
EMDN: W0104080209
EMDN description: MANUAL IDENTIFICATION KITS - ANAEROBES, PATHOGENS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 05:13

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MYCO WELL D-ONE 32

MS01283

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-MS01283PU
Basic UDI-DI: B-MS01283PU
Reference: MS01283
EMDN: W0104080207
EMDN description: MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 05:13

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FAECAL WELL D‐ONE

MS01282

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-MS01282PS
Basic UDI-DI: B-MS01282PS
Reference: MS01282
EMDN: W0104080209
EMDN description: MANUAL IDENTIFICATION KITS - ANAEROBES, PATHOGENS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 05:13

Manufacturer products View details

UROGEN WELL D-ONE

MS01281

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-MS01281PQ
Basic UDI-DI: B-MS01281PQ
Reference: MS01281
EMDN: W0104080207
EMDN description: MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 05:13

Manufacturer products View details

Cowingene MRSA/SA Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-HG06HS
Basic UDI-DI: B-HG06HS
Reference: HG06021X, HG06022X, HG06023W
EMDN: W0104080504
EMDN description: TARGETED RESISTANCE TESTS - MRSA
First on market country: Spain
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:54

Manufacturer products Authorised representative products Authorised representative actors View details

CARBA 5 In 1 Rapid Test Cassette

GCCRE-T1402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCRE-T1402aHGFX
Basic UDI-DI: B-GCCRE-T1402aHGFX
Reference: GCCRE-T1402a
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

MDR-Q Real-Time PCR Kit

G2M707521

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M707521G5
Basic UDI-DI: B-G2M707521G5
Reference: G2M707521,G2M707521R
EMDN: W0104080607
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

Bacitracin disc

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Microbiol S.r.l.
Manufacturer SRN: IT-MF-000052547
UDI-DI: 08057920720879
Basic UDI-DI: 8057920MICANTDISCHILL
Reference: MICB04-50
EMDN: W0104080502
EMDN description: IMPREGNATED DISKS, MULTI-DISKS & TABLETS
First on market country: -
Authorised representative: -
Last updated: 13.07.2026 22:59

Manufacturer products View details

Metronidazolo disc

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Microbiol S.r.l.
Manufacturer SRN: IT-MF-000052547
UDI-DI: 08057920720886
Basic UDI-DI: 8057920MICANTDISCHILL
Reference: MICMET50-50
EMDN: W0104080502
EMDN description: IMPREGNATED DISKS, MULTI-DISKS & TABLETS
First on market country: -
Authorised representative: -
Last updated: 13.07.2026 22:59

Manufacturer products View details