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Active filter:Manufacturer SRN:TW-MF-000023414

18 device results listed.

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VitaSIRO solo™ MT-RNR1 SNP Wild Type External Control Set

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570800
Basic UDI-DI: B-04719878570800
Reference: PCRAD1172
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 25.09.2026 17:43

Manufacturer products Authorised representative products Authorised representative actors View details

VitaSIRO solo™ MT-RNR1 SNP Variant External Control Set

PCRAD1171

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570626
Basic UDI-DI: B-04719878570626
Reference: PCRAD1171
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 25.09.2026 17:43

Manufacturer products Authorised representative products Authorised representative actors View details

VitaPCR Flu A&B Assay

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570022
Basic UDI-DI: B-04719878570022
Reference: PCRAE0103
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

VitaPCR Instrument

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570039
Basic UDI-DI: 471987857PCRAC0101RG
Reference: PCRAC0101
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

VitaPCR Flu/RSV Assay

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570084
Basic UDI-DI: B-04719878570084
Reference: PCRAE0106
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

VitaPCR Strep A

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570091
Basic UDI-DI: B-04719878570091
Reference: PCRAE0107
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

VitaPCR SARS-CoV-2 Assay

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570169
Basic UDI-DI: B-04719878570169
Reference: PCRAE0114
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

VitaPCR SARS-CoV-2 External Control Set

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570176
Basic UDI-DI: B-04719878570176
Reference: PCRAE0115
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

VitaPCR SARS-CoV-2 Gen 2 Assay

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570220
Basic UDI-DI: B-04719878570220
Reference: PCRAE0120
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

VitaPCR Influenza/SARS-CoV-2 (Flu/SC2) Assay

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570312
Basic UDI-DI: B-04719878570312
Reference: PCRAE0128
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

VitaPCR SARS-CoV-2 Gen 2 External Control Set

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570428
Basic UDI-DI: B-04719878570428
Reference: PCRAE0135
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

VitaPCR Flu A&B External Control Set

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570435
Basic UDI-DI: B-04719878570435
Reference: PCRAE0136
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

VitaPCR RSV External Control Set

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570442
Basic UDI-DI: B-04719878570442
Reference: PCRAE0137
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

VitaSIRO solo Instrument

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570466
Basic UDI-DI: 471987857PCRAC1101RP
Reference: PCRAC1101
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

VitaSIRO solo SARS-CoV-2/Flu/RSV Assay

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570527
Basic UDI-DI: B-04719878570527
Reference: PCRAD1102
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

VitaSIRO solo SARS-CoV-2/Flu/RSV External Control Set

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570534
Basic UDI-DI: B-04719878570534
Reference: PCRAD1106
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

VitaSIRO solo HPV Assay

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570541
Basic UDI-DI: B-04719878570541
Reference: PCRAD1104/ PCRAD1114
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

VitaSIRO solo MT-RNR1 SNP Assay

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570602
Basic UDI-DI: B-04719878570602
Reference: PCRAD1115
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details