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xPOC Cartridge

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingReagent

Manufacturer: GENSPEED Biotech
Manufacturer SRN: AT-MF-000013008
UDI-DI: 09120131770038
Basic UDI-DI: 912013177xPOCCartS4
Reference: GSPC2
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:42

Manufacturer products View details

Vitamin D xPOC

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: GENSPEED Biotech
Manufacturer SRN: AT-MF-000013008
UDI-DI: 09120131770021
Basic UDI-DI: 912013177VitaminD3CJ
Reference: IATK215
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:42

Manufacturer products View details

femSense

Class IMDR 2017/745On the marketActive deviceDirect markingSingle use

Manufacturer: SteadySense GmbH
Manufacturer SRN: AT-MF-000003984
UDI-DI: 09120095900052
Basic UDI-DI: 912009590FEM012L
Reference: 09120095900052
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:39

Manufacturer products View details

OvuFind

OVFRPD-01 OVFRPD-02

IVD Class BIVDR 2017/746On the marketDirect markingKitSelf testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 08905459006721
Basic UDI-DI: 8905459OVULHRDTSFA5
Reference: OVFRPD-01 OVFRPD-02
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

Laboquick

LBOV.01

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Ltd. Sti.
Manufacturer SRN: TR-MF-000032257
UDI-DI: 08699195610297
Basic UDI-DI: 8699195610LBOV.015Q
Reference: LBOV.01
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 31.07.2026 23:41

Manufacturer products View details

Multi-Drugs Test Panel(Urine)

DOA-1x4a-001-25M

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910581
Basic UDI-DI: 69798909110042CT
Reference: DOA-1x4a-001-25M
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:53

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Drug 5 Drugs Test Panel(Urine)

DOA-154a-001-25M

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910567
Basic UDI-DI: 69798909110060CV
Reference: DOA-154a-001-25M
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:53

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Drug 4 Drugs Test Panel(Urine)

DOA-144a-001-25M

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910574
Basic UDI-DI: 69798909110059DC
Reference: DOA-144a-001-25M
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:53

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Drug 6 Drugs Test Panel(Urine)

DOA-164a-001-25M

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910550
Basic UDI-DI: 69798909110061CX
Reference: DOA-164a-001-25M
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:53

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Drug 7 Drugs Test Panel(Urine)

DOA-174a-001-25M

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910543
Basic UDI-DI: 69798909110062CZ
Reference: DOA-174a-001-25M
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:53

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Drug 8 Drugs Test Panel(Urine)

DOA-184a-001-25M

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910536
Basic UDI-DI: 69798909110063D3
Reference: DOA-184a-001-25M
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:53

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Drug 9 Drugs Test Panel(Urine)

DOA-194a-001-25M

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910529
Basic UDI-DI: 69798909110064D5
Reference: DOA-194a-001-25M
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:53

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Drug 10 Drugs Test Panel(Urine)

DOA-1104a-001-25M

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910512
Basic UDI-DI: 69798909110065D7
Reference: Multi-Drug 10 Drugs Test Panel(Urine)
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:53

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Drug 11 Drugs Test Panel(Urine)

DOA-1114a-001-25M

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910499
Basic UDI-DI: 69798909110066D9
Reference: DOA-1114a-001-25M
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:53

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Drug 12 Drugs Test Panel(Urine)

DOA-1124a-001-25M

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910482
Basic UDI-DI: 69798909110067DB
Reference: DOA-1124a-001-25M
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:53

Manufacturer products Authorised representative products Authorised representative actors View details

BIO-INSTANT

25T/kit

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Hangzhou ELIT Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000043511
UDI-DI: 06976667950030
Basic UDI-DI: 697666795DOAZ8
Reference: EDOA-124~1144
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Türkiye
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

Prostate- Specific Antigen (PSA) Rapid Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983190701
Basic UDI-DI: 6970277510015EY7
Reference: TPS-NQ402H-01
EMDN: W0102160202
EMDN description: PSA - RT & POC
First on market country: Ireland
Safety summary (SSCP/SSP): RTD007804-SSP · Rev. 3
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Multi- Drug Rapid Test

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983143264
Basic UDI-DI: 6970277510013DXX
Reference: DOA-N1144-001
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:12

Manufacturer products Authorised representative products Authorised representative actors View details

Multi- Drug Rapid Test

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983143257
Basic UDI-DI: 6970277510013CXV
Reference: DOA-N1124-002
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:12

Manufacturer products Authorised representative products Authorised representative actors View details

Multi- Drug Rapid Test

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983143233
Basic UDI-DI: 6970277510013AXR
Reference: DOA-N1104-020
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:12

Manufacturer products Authorised representative products Authorised representative actors View details