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R&D DIAGNOSTICS OSMMR2000 G-6-PD NORMAL CONTROL

OSMMR2000 G-6-PD NORMAL CONTROL

IVD generalIVDDOn the marketNo EU repHuman tissuesProfessional testingReagent

Manufacturer: N.DIMOPOULOS ANONYMI EISAGOGIKI KAI EMPORIKI ETAIRIA.
Manufacturer SRN: EL-MF-000058573
UDI-DI: 05214002627126
Basic UDI-DI: B-05214002627126
Reference: 403-106
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Greece
Authorised representative: -
Last updated: 21.09.2026 19:23

Manufacturer products View details

R&D DIAGNOSTICS OSMMR2000 G-6-PD DEFICIENT CONTROL

OSMMR2000 G-6-PD DEFICIENT CONTROL

IVD generalIVDDOn the marketNo EU repHuman tissuesProfessional testingReagent

Manufacturer: N.DIMOPOULOS ANONYMI EISAGOGIKI KAI EMPORIKI ETAIRIA.
Manufacturer SRN: EL-MF-000058573
UDI-DI: 05214002627119
Basic UDI-DI: B-05214002627119
Reference: 403-107
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Greece
Authorised representative: -
Last updated: 21.09.2026 19:23

Manufacturer products View details

Blood Ketone Control solution

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-HSCKET-L(AT)TA
Basic UDI-DI: B-HSCKET-L(AT)TA
Reference: HSCKET-L
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 18:07

Manufacturer products Authorised representative products Authorised representative actors View details

CQI - Materiale di Controllo FOB (Sangue Occulto Fecale), Liofilo, Livello 1 e 2

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Polymed Srl
Manufacturer SRN: IT-MF-000049570
UDI-DI: 80516871100108
Basic UDI-DI: B-80516871100108
Reference: PM20101
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 21.09.2026 18:07

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Urinalysis Control

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-SCURS-L(AT)XX
Basic UDI-DI: B-SCURS-L(AT)XX
Reference: SCURS-L
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:33

Manufacturer products Authorised representative products Authorised representative actors View details

Uric Acid Control solution

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-HSCUA-L(AT)F3
Basic UDI-DI: B-HSCUA-L(AT)F3
Reference: HSCUA-L
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:27

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin (Hb) Control Solution

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-HSCHB-L(AT)7V
Basic UDI-DI: B-HSCHB-L(AT)7V
Reference: HSCHB-L
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:26

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Control solution

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-HSCGLU-L(AT)V4
Basic UDI-DI: B-HSCGLU-L(AT)V4
Reference: HSCGLU-L
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:26

Manufacturer products Authorised representative products Authorised representative actors View details

Cholesterol Control solution

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-HSCCHO-L(AT)LN
Basic UDI-DI: B-HSCCHO-L(AT)LN
Reference: HSCCHO-L
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:26

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Control Material

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984062044
Basic UDI-DI: 6970341680320200101JD
Reference: 0320200301
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.08.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

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

5'-NT Control

IVD Class BNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415986223
Basic UDI-DI: 6944904000435-NT*******ZV
Reference: 105-020475-00
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
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

ADA Control

IVD Class BNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415986315
Basic UDI-DI: 694490400043ADA********WS
Reference: 105-020473-00
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
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

AFU Control

please see UDI-DI for details

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415986421
Basic UDI-DI: 694490400043AFU********F3
Reference: 105-020474-00
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
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

CO2 and TBA Multi Control

105-020476-00

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415986452
Basic UDI-DI: 694490400046CO2TBACon**HL
Reference: 105-020476-00
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
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

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

Multichem CSF Plus

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Techno-path Manufacturing Ltd.
Manufacturer SRN: IE-MF-000001822
UDI-DI: 05391523442558
Basic UDI-DI: 539152344CHEM185S
Reference: 10631686190
EMDN: W0101050208
EMDN description: CSF CONTROLS
First on market country: Ireland
Authorised representative: -
Last updated: 11.08.2026 23:51

Manufacturer products View details

Multichem MS Free TDMs

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Techno-path Manufacturing Ltd.
Manufacturer SRN: IE-MF-000001822
UDI-DI: 05391523442473
Basic UDI-DI: 539152344CHEM115C
Reference: 10162066190
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Ireland
Authorised representative: -
Last updated: 11.08.2026 23:51

Manufacturer products View details

Multichem MS ISDs

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Techno-path Manufacturing Ltd.
Manufacturer SRN: IE-MF-000001822
UDI-DI: 05391523442381
Basic UDI-DI: 539152344CHEM145J
Reference: 09922598190
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Ireland
Authorised representative: -
Last updated: 11.08.2026 23:51

Manufacturer products View details