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184 device results listed.

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Vaginal pH Control

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrVPHLC69
Basic UDI-DI: B-acrVPHLC69
Reference: acrVPHLC
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:55

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin (Hb) Control Solution

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrBCHB-LSQ
Basic UDI-DI: B-acrBCHB-LSQ
Reference: acrBCHB-L
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details

FUN Control

105-002195-00、105-002196-00、105-002197-00、105-020477-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415986476
Basic UDI-DI: 69449040004EFUN********G8
Reference: 105-020477-00
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 12.08.2026 00:10

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis Control

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-SCURS-LDG
Basic UDI-DI: B-SCURS-LDG
Reference: SCURS-L
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 11.08.2026 23:35

Manufacturer products Authorised representative products Authorised representative actors View details

CQI Materiale di Controllo FOB, Liquido

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Polymed Srl
Manufacturer SRN: IT-MF-000049570
UDI-DI: D-IT-MF-000049570D9
Basic UDI-DI: B-IT-MF-000049570D9
Reference: PM20102
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 08.08.2026 02:05

Manufacturer products View details

Specific Protein Control Serum

3x1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202229602
Basic UDI-DI: B-06942202229602
Reference: 3003153
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

Specific Protein Control Serum

3x1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202229619
Basic UDI-DI: B-06942202229619
Reference: 3003159
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 06.08.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin D Control – botiss CARE Rapi-D™ Quantitative Vitamin D Test

1156-VDC

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Affimedix, Inc.
Manufacturer SRN: US-MF-000053178
UDI-DI: 00850082432172
Basic UDI-DI: B-00850082432172
Reference: 1156-VDC
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 06.08.2026 06:57

Manufacturer products Authorised representative products Authorised representative actors View details

Specific Protein Control Serum

Level2: 1×1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202247217
Basic UDI-DI: B-06942202247217
Reference: 3003157
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

Specific Protein Control Serum

Level1: 1×1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202247200
Basic UDI-DI: B-06942202247200
Reference: 3003151
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

06930317801059

Type C4: R1, R2, R3 and R4 (4 pcs. respectively)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317801059
Basic UDI-DI: B-06930317801059
Reference: DNK-1901-2
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:35

Manufacturer products Authorised representative products Authorised representative actors View details

06930317801042

Type C2: R1, R2, R3 and R4 (2 pcs. respectively)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317801042
Basic UDI-DI: B-06930317801042
Reference: DNK-1901-2
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:35

Manufacturer products Authorised representative products Authorised representative actors View details

06930317801035

Type C1: R1, R2, R3 and R4 (1 pc. respectively)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317801035
Basic UDI-DI: B-06930317801035
Reference: DNK-1901-2
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:34

Manufacturer products Authorised representative products Authorised representative actors View details

06930317801028

Type B4: R1, R2 and R4 (4 pcs. respectively)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317801028
Basic UDI-DI: B-06930317801028
Reference: DNK-1901-2
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:34

Manufacturer products Authorised representative products Authorised representative actors View details

06930317800809

Type A1: R2 and R4 (1 pc. respectively)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317800809
Basic UDI-DI: B-06930317800809
Reference: DNK-1901-2
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:34

Manufacturer products Authorised representative products Authorised representative actors View details

06930317800755

Type A2: R2 and R4 (2 pcs. respectively)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317800755
Basic UDI-DI: B-06930317800755
Reference: DNK-1901-2
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:34

Manufacturer products Authorised representative products Authorised representative actors View details

06930317800748

Type A4: R2 and R4 (4 pcs. respectively)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317800748
Basic UDI-DI: B-06930317800748
Reference: DNK-1901-2
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:34

Manufacturer products Authorised representative products Authorised representative actors View details

06930317800731

Type B1: R1, R2 and R4 (1 pc. respectively)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317800731
Basic UDI-DI: B-06930317800731
Reference: DNK-1901-2
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:34

Manufacturer products Authorised representative products Authorised representative actors View details

06930317800724

Type B2: R1, R2 and R4 (2 pcs. respectively)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317800724
Basic UDI-DI: B-06930317800724
Reference: DNK-1901-2
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:34

Manufacturer products Authorised representative products Authorised representative actors View details

BIOHIT Lactase Control

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587020181
Basic UDI-DI: B-06419587020181
Reference: 602018
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:51

Manufacturer products View details