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163 device results listed.

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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: 05.07.2026 11:05

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin D Control – CrinoCheck® Vitamin D

A-VITD-K

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Affimedix, Inc.
Manufacturer SRN: US-MF-000053178
UDI-DI: 00850082432165
Basic UDI-DI: B-00850082432165
Reference: A-VITD-K
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 05.07.2026 11:05

Manufacturer products Authorised representative products Authorised representative actors View details

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

1155-VDC

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Affimedix, Inc.
Manufacturer SRN: US-MF-000053178
UDI-DI: 00850082432158
Basic UDI-DI: B-00850082432158
Reference: 1155-VDC
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 05.07.2026 11:05

Manufacturer products Authorised representative products Authorised representative actors View details

Control Kit - PHOS L1

92-201353-00

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingSingle use

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000029697
UDI-DI: 00850011135433
Basic UDI-DI: B-00850011135433
Reference: 92-201353-00
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva® Optical Control Kit

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

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793041133
Basic UDI-DI: 843079304113333
Reference: AC1002
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:26

Manufacturer products Authorised representative products Authorised representative actors View details

Prism Control Clini5

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Callegari S.r.l.
Manufacturer SRN: IT-MF-000035568
UDI-DI: 80575028800193
Basic UDI-DI: 80575028800193U
Reference: AD-12060-A
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:36

Manufacturer products 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: 02.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

05902643962279

BioPath R

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643962279
Basic UDI-DI: 59026439CBCH814BT
Reference: 1-814-0001
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:28

Manufacturer products View details

05902643962262

BioNorm R

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643962262
Basic UDI-DI: 59026439CBCH813BR
Reference: 1-813-0001
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:28

Manufacturer products View details

05902643962255

KONTROLA CRP - Poziom 2 (1 ml)

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643962255
Basic UDI-DI: 59026439CBCH812BP
Reference: 1-812-0001
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:28

Manufacturer products View details

05902643962248

KONTROLA CRP - Poziom 1 (1 ml)

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643962248
Basic UDI-DI: 59026439CBCH811BM
Reference: 1-811-0001
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:28

Manufacturer products View details

Multichem MS VItD

Multichem MS VitD

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Techno-path Manufacturing Ltd.
Manufacturer SRN: IE-MF-000001822
UDI-DI: 05391523442367
Basic UDI-DI: 539152344CHEM155L
Reference: 09922555190
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 02.07.2026 03:14

Manufacturer products View details

HbA1c CONTROL

HbA1c

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Medicon Hellas SA
Manufacturer SRN: GR-MF-000013625
UDI-DI: 05204309162215
Basic UDI-DI: 5204309000026NU
Reference: 1578-1057
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Greece
Authorised representative: -
Last updated: 02.07.2026 02:53

Manufacturer products View details

TOTAL ANTIOXIDANT STATUS (TAS CONTROL)

TOTAL ANTIOXIDANT STATUS CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273204728
Basic UDI-DI: 50552732BTTATSS111Y8
Reference: NX2331
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:44

Manufacturer products View details

Vivadiag Plus

IVD generalNot specifiedOn the market

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339204288
Basic UDI-DI: B-06937339204288
Reference: VOC02-011
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

Vivadiag Plus

IVD generalNot specifiedOn the market

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339204271
Basic UDI-DI: B-06937339204271
Reference: VOC01-011
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

sLDL CONTROL LEVEL 2 (sLDL CONTROL 2)

IVD Class BNot specifiedOn the marketNo EU rep

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273209082
Basic UDI-DI: 50552732BSLDLCL099K6
Reference: LE5014
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 21.06.2026 21:35

Manufacturer products View details

sLDL CONTROL LEVEL 3 (sLDL CONTROL 3)

IVD Class BNot specifiedOn the marketNo EU rep

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273209099
Basic UDI-DI: 50552732BSLDLCL099K6
Reference: LE5015
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 21.06.2026 21:35

Manufacturer products View details

Multichem MS VItD

IVD Class BNot specifiedOn the market

Manufacturer: Techno-path Manufacturing Ltd.
Manufacturer SRN: IE-MF-000001822
UDI-DI: 05391523442374
Basic UDI-DI: 539152344CHEM155L
Reference: 09922563190
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 20.06.2026 05:37

Manufacturer products View details

04260674450136

IVD generalNot specifiedOn the market

Manufacturer: invicon diagnostic concepts GmbH
Manufacturer SRN: DE-MF-000031071
UDI-DI: 04260674450136
Basic UDI-DI: B-04260674450136
Reference: 110150
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 18.06.2026 03:43

Manufacturer products View details