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15 device results listed.

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PoET HBV

IVD Annex II List AIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
Manufacturer SRN: DE-MF-000025295
UDI-DI: 04262353370049
Basic UDI-DI: B-04262353370049
Reference: P2B-28-30
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:54

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PoET Instrument

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
Manufacturer SRN: DE-MF-000025295
UDI-DI: 04262353370162
Basic UDI-DI: 42623533727MF
Reference: P9A
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 23:26

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PoET Prep Reagent

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
Manufacturer SRN: DE-MF-000025295
UDI-DI: 04262353370018
Basic UDI-DI: 42623533712M2
Reference: P1B-24-20
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 23:26

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PoET Extraction

IVD Class AIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
Manufacturer SRN: DE-MF-000025295
UDI-DI: 04262353370001
Basic UDI-DI: 42623533711LY
Reference: P1A-24-04
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 23:26

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PoET Negative Control

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
Manufacturer SRN: DE-MF-000025295
UDI-DI: 04262353370209
Basic UDI-DI: B-04262353370209
Reference: P3A-500-30
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Germany
Authorised representative: -
Last updated: 18.06.2026 05:44

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PoET Internal Control

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
Manufacturer SRN: DE-MF-000025295
UDI-DI: 04262353370193
Basic UDI-DI: B-04262353370193
Reference: P1C-1440-60
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Germany
Authorised representative: -
Last updated: 18.06.2026 05:44

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PoET WNV Positive Control

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
Manufacturer SRN: DE-MF-000025295
UDI-DI: 04262353370155
Basic UDI-DI: B-04262353370155
Reference: P3H-180-30
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Germany
Authorised representative: -
Last updated: 18.06.2026 05:44

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PoET HEV Positive Control

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
Manufacturer SRN: DE-MF-000025295
UDI-DI: 04262353370131
Basic UDI-DI: B-04262353370131
Reference: P3F-180-30
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Germany
Authorised representative: -
Last updated: 18.06.2026 05:44

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PoET Master Positive Control

IVD Annex II List ANot specifiedOn the marketSingle use

Manufacturer: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
Manufacturer SRN: DE-MF-000025295
UDI-DI: 04262353370124
Basic UDI-DI: B-04262353370124
Reference: P3B-360-30
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Germany
Authorised representative: -
Last updated: 18.06.2026 05:44

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PoET WNV

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
Manufacturer SRN: DE-MF-000025295
UDI-DI: 04262353370100
Basic UDI-DI: B-04262353370100
Reference: P2H-28-30
EMDN: W0105040526
EMDN description: WEST NILE VIRUS - NA REAGENT
First on market country: Germany
Authorised representative: -
Last updated: 18.06.2026 05:44

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PoET HEV

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
Manufacturer SRN: DE-MF-000025295
UDI-DI: 04262353370087
Basic UDI-DI: B-04262353370087
Reference: P2F-28-30
EMDN: W0105020507
EMDN description: HEPATITIS E VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 18.06.2026 05:44

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PoET B19V

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
Manufacturer SRN: DE-MF-000025295
UDI-DI: 04262353370070
Basic UDI-DI: B-04262353370070
Reference: P2E-28-30
EMDN: W0105040509
EMDN description: PARVOVIRUS B 19 - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 18.06.2026 05:44

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PoET HAV

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
Manufacturer SRN: DE-MF-000025295
UDI-DI: 04262353370063
Basic UDI-DI: B-04262353370063
Reference: P2D-28-30
EMDN: W0105020105
EMDN description: HEPATITIS A VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 18.06.2026 05:44

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PoET HIV

IVD Annex II List ANot specifiedOn the marketSingle use

Manufacturer: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
Manufacturer SRN: DE-MF-000025295
UDI-DI: 04262353370056
Basic UDI-DI: B-04262353370056
Reference: P2C-28-30
EMDN: W0105030405
EMDN description: HIV MULTIPLE - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 18.06.2026 05:44

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PoET HCV

IVD Annex II List ANot specifiedOn the marketSingle use

Manufacturer: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
Manufacturer SRN: DE-MF-000025295
UDI-DI: 04262353370032
Basic UDI-DI: B-04262353370032
Reference: P2A-28-30
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 18.06.2026 05:44

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