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06973262865554

EXM3000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262865554
Basic UDI-DI: 69732628600004ZE
Reference: 02-14-01-0013-00
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06973262864403

EXP 160R, EXP 161R

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262864403
Basic UDI-DI: 69732628600003ZC
Reference: 02-17-01-0004-00
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06973262864373

EXP 160, EXP 161, EXP 162

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262864373
Basic UDI-DI: 69732628600002ZA
Reference: 02-17-01-0007-00
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

Quantitative Real-time PCR System

EXP 960, EXP 961, EXP 962, EXP 963

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967205173
Basic UDI-DI: 697326286000792G
Reference: 02-17-01-0021-00
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

Real-Time PCR System

N 904

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Maccura Medical Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000028087
UDI-DI: 06972168355015
Basic UDI-DI: 6972168353201AA
Reference: EGN9101002
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Türkiye
Authorised representative: Humiss International B.V.
Last updated: 02.07.2026 12:35

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Nucleic Acid Extraction System

N 32，N 96

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Maccura Medical Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000028087
UDI-DI: 06972168350775
Basic UDI-DI: 6972168353003A4
Reference: EGN9101006
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 02.07.2026 12:35

Manufacturer products Authorised representative products Authorised representative actors View details

Vanadis View

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147369324
Basic UDI-DI: 6438147Vanadis_ViewVE
Reference: 2028-0020
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

Vanadis Core

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147369317
Basic UDI-DI: 6438147Vanadis_CoreSA
Reference: 2027-0020
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

Vanadis Extract

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147369300
Basic UDI-DI: 6438147Vanadis_Extract9Y
Reference: 2026-0020
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

Novodiag Instrument

Novodiag System

IVD Class AIVDR 2017/746No longer on the marketInstrumentProfessional testing

Manufacturer: Mobidiag Ltd.
Manufacturer SRN: FI-MF-000001215
UDI-DI: 06430041760030
Basic UDI-DI: 643004176B0039MJ
Reference: NVD-INST-B
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 08:54

Manufacturer products View details

BasePurifier

BasePurifier™ 32 Nucleic Acid Extraction System 32 Oscillating Rods

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: 05713915000533
Basic UDI-DI: 5713915BP001NK
Reference: 715
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Denmark
Authorised representative: -
Last updated: 02.07.2026 04:52

Manufacturer products View details

BaseTyper

BaseTyper™ 96.4 Flexible Real-Time PCR System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: 05713915000557
Basic UDI-DI: 5713915BT004PM
Reference: 759
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Denmark
Authorised representative: -
Last updated: 02.07.2026 04:52

Manufacturer products View details

BaseTyper

BaseTyper™ 96.6 Flexible Real-Time PCR System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: 05713915000540
Basic UDI-DI: 5713915BT003PK
Reference: 758
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Denmark
Authorised representative: -
Last updated: 02.07.2026 04:52

Manufacturer products View details

BasePurifier

BasePurifier™ 96 Nucleic Acid Extraction System 96 Rotating Rods

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: 05713915000526
Basic UDI-DI: 5713915BP002NM
Reference: 719
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Denmark
Authorised representative: -
Last updated: 02.07.2026 04:52

Manufacturer products View details

BasePurifier

BasePurifier™ 48 Large Volume Nucleic Acid Extraction System 48 Rotating Rods

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: 05713915000519
Basic UDI-DI: 5713915BP003NP
Reference: 718
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Denmark
Authorised representative: -
Last updated: 02.07.2026 04:52

Manufacturer products View details

BaseTyper

BaseTyper™ 16.2 Portable Real-Time PCR System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: 05713915000144
Basic UDI-DI: 5713915BT002PH
Reference: 712
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Denmark
Authorised representative: -
Last updated: 02.07.2026 04:52

Manufacturer products View details

BaseTyper

BaseTyper™ 48.4 Quiet HRM Real-Time PCR System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: 05713915000014
Basic UDI-DI: 5713915BT001PF
Reference: 754
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Denmark
Authorised representative: -
Last updated: 02.07.2026 04:52

Manufacturer products View details

NeXgen 16HP

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Zinexts Life Science Corp.
Manufacturer SRN: TW-MF-000026758
UDI-DI: 04719889680154
Basic UDI-DI: 471988968AA131F6
Reference: 131A1
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 00:31

Manufacturer products Authorised representative products Authorised representative actors View details

04719880129751

SLA-E13200

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentProfessional testing

Manufacturer: Taiwan Advanced Nanotech Inc.
Manufacturer SRN: TW-MF-000019040
UDI-DI: 04719880129751
Basic UDI-DI: 471988012SLAE1320044
Reference: SLA-E13200
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
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

04719880129485

Maelstrom 9600

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentProfessional testing

Manufacturer: Taiwan Advanced Nanotech Inc.
Manufacturer SRN: TW-MF-000019040
UDI-DI: 04719880129485
Basic UDI-DI: 471988012M96007R
Reference: Maelstrom 9600 (110V)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
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