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

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Novolink DAB (Polymer) 250 tests

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IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 05055331301901
Basic UDI-DI: 50553313NOVDAB00004XS
Reference: RE7230-K
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 21.06.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

Novolink Polymer

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IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 05055331301925
Basic UDI-DI: 50553313NOVPOL00004JH
Reference: RE7200-K
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 21.06.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

Novolink Polymer Detection System (500 tests)

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IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 05055331301987
Basic UDI-DI: 50553313NVPLDT00004FK
Reference: RE7150-K
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 21.06.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

Novocastra Polymer Detection System (250 tests)

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IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
UDI-DI: 05055331301994
Basic UDI-DI: 50553313NVPLDT00004FK
Reference: RE7140-K
EMDN: W01030799
EMDN description: PRIMARY ANTISERA FOR IMMUNOHISTOLOGY
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 21.06.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

PathTezt Preserve Cell Solution 926ml (Methanol Based)

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IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Biocytech Corporation Sdn Bhd
Manufacturer SRN: MY-MF-000047354
UDI-DI: 09551020410047
Basic UDI-DI: 955102041CellH2
Reference: PCS-926
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 21.06.2026 17:13

Manufacturer products Authorised representative products Authorised representative actors View details

PathTezt Cytolysis Solution 926ml

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IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Biocytech Corporation Sdn Bhd
Manufacturer SRN: MY-MF-000047354
UDI-DI: 09551020410054
Basic UDI-DI: 955102041CellH2
Reference: CTLS-9260604
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 21.06.2026 17:13

Manufacturer products Authorised representative products Authorised representative actors View details

PathTezt Preserve Cell Solution 20ml (Methanol Based)

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IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Biocytech Corporation Sdn Bhd
Manufacturer SRN: MY-MF-000047354
UDI-DI: 09551020410108
Basic UDI-DI: 955102041CellH2
Reference: PCS-200920
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 21.06.2026 17:13

Manufacturer products Authorised representative products Authorised representative actors View details

EasyVial Preserve Cell Solution 15ml

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IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Biocytech Corporation Sdn Bhd
Manufacturer SRN: MY-MF-000047354
UDI-DI: 09551020410115
Basic UDI-DI: 955102041CellH2
Reference: EV-60010
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 21.06.2026 17:13

Manufacturer products Authorised representative products Authorised representative actors View details

PathTezt Density Reagent

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IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Biocytech Corporation Sdn Bhd
Manufacturer SRN: MY-MF-000047354
UDI-DI: 09551020410146
Basic UDI-DI: 955102041CellH2
Reference: PDR-1000
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 21.06.2026 17:13

Manufacturer products Authorised representative products Authorised representative actors View details

PathTezt Preserve Cell Solution 10ml (Ethanol Based)

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IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Biocytech Corporation Sdn Bhd
Manufacturer SRN: MY-MF-000047354
UDI-DI: 09551020410221
Basic UDI-DI: 955102041CellH2
Reference: PCS-200910E
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 21.06.2026 17:13

Manufacturer products Authorised representative products Authorised representative actors View details

PathTezt Preserve Cell Solution 5ml (Methanol Based)

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IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Biocytech Corporation Sdn Bhd
Manufacturer SRN: MY-MF-000047354
UDI-DI: 09551020410238
Basic UDI-DI: 955102041CellH2
Reference: PCS-200905
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 21.06.2026 17:13

Manufacturer products Authorised representative products Authorised representative actors View details

PathTezt Preserve Cell Solution 3ml (Methanol Based)

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IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Biocytech Corporation Sdn Bhd
Manufacturer SRN: MY-MF-000047354
UDI-DI: 09551020410245
Basic UDI-DI: 955102041CellH2
Reference: PCS-200903
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 21.06.2026 17:13

Manufacturer products Authorised representative products Authorised representative actors View details

PathTezt Preserve Cell Solution 1ml (Methanol Based)

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IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Biocytech Corporation Sdn Bhd
Manufacturer SRN: MY-MF-000047354
UDI-DI: 09551020410252
Basic UDI-DI: 955102041CellH2
Reference: PCS-200901
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 21.06.2026 17:13

Manufacturer products Authorised representative products Authorised representative actors View details

PathTezt SelfSampler HPV Preserve Cell Solution 3ml

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IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Biocytech Corporation Sdn Bhd
Manufacturer SRN: MY-MF-000047354
UDI-DI: 09551020410269
Basic UDI-DI: 955102041CellH2
Reference: SSH-1003
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 21.06.2026 17:13

Manufacturer products Authorised representative products Authorised representative actors View details

EasyVial Preserve Cell Solution 926ml

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IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Biocytech Corporation Sdn Bhd
Manufacturer SRN: MY-MF-000047354
UDI-DI: 09551020410276
Basic UDI-DI: 955102041CellH2
Reference: EV-926
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 21.06.2026 17:13

Manufacturer products Authorised representative products Authorised representative actors View details

EasyVial Preserve Cell Solution 5ml

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IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Biocytech Corporation Sdn Bhd
Manufacturer SRN: MY-MF-000047354
UDI-DI: 09551020410283
Basic UDI-DI: 955102041CellH2
Reference: EV-60005
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 21.06.2026 17:13

Manufacturer products Authorised representative products Authorised representative actors View details

PathTezt Preserve Cell Solution 10ml (Methanol Based)

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IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Biocytech Corporation Sdn Bhd
Manufacturer SRN: MY-MF-000047354
UDI-DI: 09551020410443
Basic UDI-DI: 955102041CellH2
Reference: PCS-200910
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 21.06.2026 17:13

Manufacturer products Authorised representative products Authorised representative actors View details

PathTezt Preserve Cell Solution 1ml (Ethanol Based)

-

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Biocytech Corporation Sdn Bhd
Manufacturer SRN: MY-MF-000047354
UDI-DI: 09551020410450
Basic UDI-DI: 955102041CellH2
Reference: PCS-200901E
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 21.06.2026 17:13

Manufacturer products Authorised representative products Authorised representative actors View details

PathTezt Preserve Cell Solution 3ml (Ethanol Based)

-

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Biocytech Corporation Sdn Bhd
Manufacturer SRN: MY-MF-000047354
UDI-DI: 09551020410467
Basic UDI-DI: 955102041CellH2
Reference: PCS-200903E
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 21.06.2026 17:13

Manufacturer products Authorised representative products Authorised representative actors View details

PathTezt Preserve Cell Solution 5ml (Ethanol Based)

-

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Biocytech Corporation Sdn Bhd
Manufacturer SRN: MY-MF-000047354
UDI-DI: 09551020410474
Basic UDI-DI: 955102041CellH2
Reference: PCS-200905E
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 21.06.2026 17:13

Manufacturer products Authorised representative products Authorised representative actors View details