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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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mariPOC® Extraction solution B

mariPOC® Extraction solution B

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: 06430080370368
Basic UDI-DI: 643008037B03BXN
Reference: B03B
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:00

Manufacturer products View details

mariPOC® Extraction solution A

mariPOC® Extraction solution A

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: 06430080370351
Basic UDI-DI: 643008037B03AXL
Reference: B03A
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:00

Manufacturer products View details

Amplidiag Easy Extraction Kit I

Amplidiag Easy Extraction Kit I

IVD Class AIVDR 2017/746No longer on the marketKitProfessional testingReagent

Manufacturer: Mobidiag Ltd.
Manufacturer SRN: FI-MF-000001215
UDI-DI: 06430041761136
Basic UDI-DI: 643004176B0010LS
Reference: AE-EXT-016
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 08:54

Manufacturer products View details

Panther Fusion Reconstitution Buffer I

-

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509252
Basic UDI-DI: 54200455DIAGFLUIDSBG
Reference: PRD-04333
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Hologic BV
Last updated: 02.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion Extraction Reagent-S

-

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509214
Basic UDI-DI: 54200455DIAGFLUIDSBG
Reference: PRD-04331
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Hologic BV
Last updated: 02.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion Elution Buffer

-

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509269
Basic UDI-DI: 54200455DIAGFLUIDSBG
Reference: PRD-04334
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Hologic BV
Last updated: 02.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion Reconstitution Buffer II

-

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045510456
Basic UDI-DI: 54200455DIAGFLUIDSBG
Reference: PRD-04804
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Hologic BV
Last updated: 02.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion Open Access RNA/DNA Enzyme Cartridge

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IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045515451
Basic UDI-DI: 54200455DIAGFLUIDSBG
Reference: PRD-04303
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Hologic BV
Last updated: 02.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion Extraction Reagent-X

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IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045510463
Basic UDI-DI: 54200455DIAGFLUIDSBG
Reference: PRD-04477
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Hologic BV
Last updated: 02.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion Oil

-

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509276
Basic UDI-DI: 54200455DIAGFLUIDSBG
Reference: PRD-04335
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Hologic BV
Last updated: 02.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion Open Access Diluent Additive

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IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045511071
Basic UDI-DI: 54200455DIAGFLUIDSBG
Reference: PRD-04945
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Hologic BV
Last updated: 02.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045516168
Basic UDI-DI: 54200455DIAGFLUIDSBG
Reference: PRD-04304
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Hologic BV
Last updated: 02.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion Extraction Reagent-B

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IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045512917
Basic UDI-DI: 54200455DIAGFLUIDSBG
Reference: PRD-06232
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: Hologic BV
Last updated: 02.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima Transfer Solution

Reagents and Fluids

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045508606
Basic UDI-DI: 54200455DIAGTRANSPORT6X
Reference: 303658
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima Auto Detect Kit

Reagents and Fluids

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045500273
Basic UDI-DI: 54200455DIAGFLUIDSBG
Reference: 303013
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:05

Manufacturer products Authorised representative products Authorised representative actors View details

β-Glucan Sample Diluent

999-04301

IVD Class AIVDR 2017/746On the marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481163819
Basic UDI-DI: 498748114987481163819ZU
Reference: 999-04301
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 02.07.2026 01:06

Manufacturer products Authorised representative products Authorised representative actors View details

685 series

IVD Class AIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Taiwan Advanced Nanotech Inc.
Manufacturer SRN: TW-MF-000019040
UDI-DI: 04719880124473
Basic UDI-DI: 471988012685GW
Reference: 685A46
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: mdi Europa GmbH
Last updated: 02.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

66P-MS series

IVD Class AIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Taiwan Advanced Nanotech Inc.
Manufacturer SRN: TW-MF-000019040
UDI-DI: 04719880124213
Basic UDI-DI: 47198801266PJC
Reference: M66PA46-MS
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: mdi Europa GmbH
Last updated: 02.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

63F series

IVD Class AIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Taiwan Advanced Nanotech Inc.
Manufacturer SRN: TW-MF-000019040
UDI-DI: 04719880124152
Basic UDI-DI: 47198801263FHF
Reference: 63FA46
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: mdi Europa GmbH
Last updated: 02.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

61H series

IVD Class AIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Taiwan Advanced Nanotech Inc.
Manufacturer SRN: TW-MF-000019040
UDI-DI: 04719880124039
Basic UDI-DI: 47198801261HHD
Reference: W61HA46
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: mdi Europa GmbH
Last updated: 02.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details