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

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21.09.2026 19:54

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Active filter:Manufacturer SRN:SG-MF-000025684

81 device results listed.

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Sentosa SX Lysis Plate (96)

300649, 300704

IVD Class AIVDR 2017/746On the marketDirect markingKitReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013958232
Basic UDI-DI: 888501395SSXLPWR
Reference: 300649
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 01.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

ViroKey HT Virus Total Nucleic Acid Kit (4x96)

300678, 301089

IVD Class AIVDR 2017/746On the marketDirect markingKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013958201
Basic UDI-DI: 888501395VKVTNA2S
Reference: 301089
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 01.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SX Virus Total Nucleic Acid Plus II Kit (4x16)

300351

IVD Class AIVDR 2017/746On the marketDirect markingKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013958126
Basic UDI-DI: 888501395SSXVTNAPlusII9L
Reference: 300351
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 01.08.2026 00:08

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SX Lysis Beads

300291

IVD Class AIVDR 2017/746On the marketDirect markingKitReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013958102
Basic UDI-DI: 888501395SSXLBVV
Reference: 300291
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 01.08.2026 00:08

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SX Whole Blood Kit (4x24)

300252

IVD Class AIVDR 2017/746On the marketDirect markingKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013958096
Basic UDI-DI: 888501395SSXWBWW
Reference: 300252
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 01.08.2026 00:08

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24)

300154

IVD Class AIVDR 2017/746On the marketDirect markingKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013958072
Basic UDI-DI: 888501395SSXVTNAPlus7G
Reference: 300154
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 01.08.2026 00:08

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24)

300042

IVD Class AIVDR 2017/746On the marketDirect markingKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013958034
Basic UDI-DI: 888501395SSXVTNAv2WK
Reference: 300042
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 01.08.2026 00:08

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SQ301 Sequencer

690025

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitReagent

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013950045
Basic UDI-DI: 888501395SSQ301P2E
Reference: 400103
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 01.08.2026 00:08

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SX101

400089

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKit

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013950007
Basic UDI-DI: 888501395SSX101TP
Reference: 400089
EMDN: W02060102
EMDN description: AUTOMATED SAMPLE TRANSPORT SYSTEMS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 01.08.2026 00:08

Manufacturer products Authorised representative products Authorised representative actors View details

ViroKey MP HPV 16, 18 PCR Test

301119, 301120, 301121

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: D-888501395VKMPHPV1618TZ6
Basic UDI-DI: B-888501395VKMPHPV1618TZ6
Reference: 301119, 301120, 301121
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 12.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

VELA Analytics

480175

IVD generalIVDDOn the market

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: D-888501395VELAAQV
Basic UDI-DI: B-888501395VELAAQV
Reference: 480175
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 12.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SQ Reporter Software

480169, 480183, 480185, 480187, 480198, 480204

IVD generalIVDDOn the marketKit

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: D-888501395SSQRep78
Basic UDI-DI: B-888501395SSQRep78
Reference: 480169, 480183, 480185, 480187, 480204
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 12.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SA vanA/vanB PCR Test

300015, 300016

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: D-888501395SSAvanABT3Q
Basic UDI-DI: B-888501395SSAvanABT3Q
Reference: 300015, 300016
EMDN: W0104080604
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED VRE
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 12.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SA HSV1/2 PCR Test (4x24)

300064

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: D-888501395SSAHSV12QLTV8
Basic UDI-DI: B-888501395SSAHSV12QLTV8
Reference: 300064
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 12.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SA HHV6 Quantitative PCR Test

300157, 300184, 300673, 300180

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: D-888501395SSAHHV6QTT4A
Basic UDI-DI: B-888501395SSAHHV6QTT4A
Reference: 300157, 300184, 300180, 300673
EMDN: W0105040524
EMDN description: HHV-6,7,8 - NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 12.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Great Basin Stool Bacterial Pathogens Panel

300780

IVD generalIVDDOn the marketKitMicrobial substancesNear-patient testingReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: D-888501395GBStoolJB
Basic UDI-DI: B-888501395GBStoolJB
Reference: 300780
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 12.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Great Basin Group B Streptococcus Test

300781

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: D-888501395GBGBSKH
Basic UDI-DI: B-888501395GBGBSKH
Reference: 300781
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 12.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Great Basin Bordetella Direct Test

300782

IVD generalIVDDOn the marketKitMicrobial substancesNear-patient testingReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: D-888501395GBBordVC
Basic UDI-DI: B-888501395GBBordVC
Reference: 300782
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 12.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

RapidKey COVID-19 Antigen Self Test (25)

301115

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013959550
Basic UDI-DI: B-08885013959550
Reference: 301115
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

RapidKey COVID-19 Antigen Self Test (7)

301114

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesSelf testingSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013959543
Basic UDI-DI: B-08885013959543
Reference: 301114
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details