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EUDAMED Device Search

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

Last updated

21.09.2026 21:15

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Active filter:EMDN:W0101060199

92 device results listed.

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H18

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: 1drop Inc.
Manufacturer SRN: KR-MF-000026103
UDI-DI: D-H1890PM
Basic UDI-DI: B-H1890PM
Reference: H18190
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 06.08.2026 23:01

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin D Test Cassette

Vitamin D Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-VD-402Q2
Basic UDI-DI: B-ACO-VD-402Q2
Reference: ACO-VD-402
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Czechia
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:29

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin B12 Test Cassette

Vitamin B12 Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-VB12-302FJ
Basic UDI-DI: B-ACO-VB12-302FJ
Reference: ACO-VB12-302
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Denmark
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:29

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Insulin Test Cassette

Insulin Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-INS-402TB
Basic UDI-DI: B-ACO-INS-402TB
Reference: ACO-INS-402
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Denmark
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:29

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Folate Test Cassette

Folate Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-FA-302GC
Basic UDI-DI: B-ACO-FA-302GC
Reference: ACO-FA-302
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Finland
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:29

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C-peptide Test Cassette

C-peptide Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-CP-402LF
Basic UDI-DI: B-ACO-CP-402LF
Reference: ACO-CP-402
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Croatia
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:28

Manufacturer products Authorised representative products Authorised representative actors View details

Uric Acid Test strips

LS-105

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Hangzhou Bosure Biotech Co., Ltd
Manufacturer SRN: CN-MF-000003001
UDI-DI: 16975519630974
Basic UDI-DI: B-16975519630974
Reference: LS-141-1
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 04.08.2026 18:44

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Safe AQ UG

IVD Annex II List BIVDDOn the marketMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175037919
Basic UDI-DI: B-06934175037919
Reference: 1V003DD
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 13:07

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KBM-K01

IVD self-testing devicesIVDDOn the marketKitMicrobial substancesNear-patient testingProfessional testingSelf testingSingle use

Manufacturer: Visgeneer Inc.
Manufacturer SRN: TW-MF-000036547
UDI-DI: 00860001641752
Basic UDI-DI: B-00860001641752
Reference: 1320757
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 22:29

Manufacturer products Authorised representative products Authorised representative actors View details

eB-K03

IVD self-testing devicesIVDDOn the marketKitMicrobial substancesNear-patient testingProfessional testingSelf testingSingle use

Manufacturer: Visgeneer Inc.
Manufacturer SRN: TW-MF-000036547
UDI-DI: 04712558761154
Basic UDI-DI: B-04712558761154
Reference: 1320588
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

eB-K04

IVD self-testing devicesIVDDOn the marketKitMicrobial substancesNear-patient testingProfessional testingSelf testingSingle use

Manufacturer: Visgeneer Inc.
Manufacturer SRN: TW-MF-000036547
UDI-DI: 04712558761130
Basic UDI-DI: B-04712558761130
Reference: 1320582
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

eB-K02

IVD self-testing devicesIVDDOn the marketKitMicrobial substancesNear-patient testingProfessional testingSelf testingSingle use

Manufacturer: Visgeneer Inc.
Manufacturer SRN: TW-MF-000036547
UDI-DI: 04712558761079
Basic UDI-DI: B-04712558761079
Reference: 1320550
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

eB-K01

IVD self-testing devicesIVDDOn the marketKitMicrobial substancesNear-patient testingProfessional testingSelf testingSingle use

Manufacturer: Visgeneer Inc.
Manufacturer SRN: TW-MF-000036547
UDI-DI: 04712558760522
Basic UDI-DI: B-04712558760522
Reference: 1320839
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

LK-02

IVD self-testing devicesIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingSelf testingSingle use

Manufacturer: Visgeneer Inc.
Manufacturer SRN: TW-MF-000036547
UDI-DI: 04712558761147
Basic UDI-DI: B-04712558761147
Reference: 1320795
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.07.2026 23:48

Manufacturer products Authorised representative products Authorised representative actors View details

D-69750225320174CEKYTW

Blood Uric Acid Test Strips

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: EAGLENOS SCIENCES, INC.
Manufacturer SRN: CN-MF-000036801
UDI-DI: D-69750225320174CEKYTW
Basic UDI-DI: B-69750225320174CEKYTW
Reference: EN400R1、EN400R2、 EN400R3、EN400R4、
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

UA01

IVD self-testing devicesIVDDOn the marketProfessional testingReagentSelf testingSingle use

Manufacturer: Guilin Royalyze Medical Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000038422
UDI-DI: D-697191378-UATSHP
Basic UDI-DI: B-697191378-UATSHP
Reference: UA01
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: Caretechion GmbH
Last updated: 17.07.2026 04:01

Manufacturer products Authorised representative products Authorised representative actors View details

HB01

IVD self-testing devicesIVDDOn the marketProfessional testingReagentSelf testingSingle use

Manufacturer: Guilin Royalyze Medical Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000038422
UDI-DI: D-697191378-HTSKG
Basic UDI-DI: B-697191378-HTSKG
Reference: HB01
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: Caretechion GmbH
Last updated: 17.07.2026 04:01

Manufacturer products Authorised representative products Authorised representative actors View details

D-69717712013448Q

-

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-69717712013448Q
Basic UDI-DI: B-69717712013448Q
Reference: 3020601001
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 03:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-69717712010478F

-

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-69717712010478F
Basic UDI-DI: B-69717712010478F
Reference: 3020100301
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 03:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-697177120106189

-

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-697177120106189
Basic UDI-DI: B-697177120106189
Reference: 3020100501
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 03:57

Manufacturer products Authorised representative products Authorised representative actors View details