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289 device results listed.

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CERA-CHEK™ Lactate Control Solution

L 400

IVD self-testing devicesIVDDOn the marketNear-patient testingSelf testing

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065181100
Basic UDI-DI: B-08800065181100
Reference: L400C10
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

IGE TÜRBİDİMETRİK KONTROL SET

IGE TURBIDIMETRIC CONTROL SET

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08699015281843
Basic UDI-DI: B-08699015281843
Reference: 01R98-01
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 16:12

Manufacturer products View details

ÇİNKO KONTROL SEVİYE II

ZINC CONTROL LEVEL II

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08681812526340
Basic UDI-DI: B-08681812526340
Reference: 06R71-11
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 08.07.2026 18:41

Manufacturer products View details

ÇİNKO KONTROL SEVİYE I

ZINC CONTROL LEVEL I

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08681812526333
Basic UDI-DI: B-08681812526333
Reference: 06R71-10
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 08.07.2026 18:41

Manufacturer products View details

D-DİMER KONTROL SET

D-DIMER CONTROL SET

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08681812526319
Basic UDI-DI: B-08681812526319
Reference: 06T04-10
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 08.07.2026 18:41

Manufacturer products View details

SPESİFİK PROTEİN KONTROL SEVİYE II (ROMATOİD KONTROL II)

SPECIFIC PROTEIN CONTROL LEVEL II (RHEUMATOID CONTROL II)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08681812526142
Basic UDI-DI: B-08681812526142
Reference: 06T81-68
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 08.07.2026 18:40

Manufacturer products View details

SPESİFİK PROTEİN KONTROL SEVİYE I (ROMATOİD KONTROL I)

SPECIFIC PROTEIN CONTROL LEVEL I (RHEUMATOID CONTROL I)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08681812526135
Basic UDI-DI: B-08681812526135
Reference: 06T81-67
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 08.07.2026 18:40

Manufacturer products View details

SPESİFİK PROTEİN KONTROL SEVİYE II (ROMATOİD KONTROL II)

SPECIFIC PROTEIN CONTROL LEVEL II (RHEUMATOID CONTROL II)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08681812526128
Basic UDI-DI: B-08681812526128
Reference: 06T81-66
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 08.07.2026 18:40

Manufacturer products View details

SPESİFİK PROTEİN KONTROL SEVİYE I (ROMATOİD KONTROL I)

SPECIFIC PROTEIN CONTROL LEVEL I (RHEUMATOID CONTROL I)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08681812526111
Basic UDI-DI: B-08681812526111
Reference: 06T81-65
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 08.07.2026 18:40

Manufacturer products View details

Kit Control OSAXYL

KCXYL

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: BIOLAN MICROBIOSENSORES S.L.
Manufacturer SRN: ES-MF-000001992
UDI-DI: 08437022705156
Basic UDI-DI: B-08437022705156
Reference: KCXYL
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 01:00

Manufacturer products View details

ADA CONTROLS

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287180480
Basic UDI-DI: B-08435287180480
Reference: 18048
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:51

Manufacturer products View details

FRUCTOSAMINE CONTROL SERUM

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287101843
Basic UDI-DI: B-08435287101843
Reference: 18057
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:41

Manufacturer products View details

HEMOGLOBIN A2 CONTROL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287100112
Basic UDI-DI: B-08435287100112
Reference: 10011
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:40

Manufacturer products View details

CONTROL FOR BIOGENIC AMINES IN URINE - LEVELS 1 AND 2

Control for Biogenic Amines in urine - Levels 1 and 2

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing

Manufacturer: EUREKA S.R.L. LAB DIVISION
Manufacturer SRN: IT-MF-000034499
UDI-DI: 08033673124089
Basic UDI-DI: B-08033673124089
Reference: Z10559
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 12:16

Manufacturer products View details

FORA Control Solution KB Level 2

𝝱-Ketone Control Solution

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 07640143658299
Basic UDI-DI: B-07640143658299
Reference: ACS028
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

FORA Control Solution UA Normal

Uric Acid Control Solution

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 07640143658251
Basic UDI-DI: B-07640143658251
Reference: ACS031
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

FORA Control Solution TCH Normal

Total Cholesterol Control Solution

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 07640143658220
Basic UDI-DI: B-07640143658220
Reference: ACS030
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

Vaginitis Diagnosis Quality Control Kit

Vaginitis Diagnosis Quality Control Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Lituo Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000026852
UDI-DI: 06972235844947
Basic UDI-DI: B-06972235844947
Reference: LTA120101
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

SS-273

IVD generalIVDDOn the marketKit

Manufacturer: ELITechGroup Inc.
Manufacturer SRN: US-MF-000006942
UDI-DI: 03661540300196
Basic UDI-DI: B-03661540300196
Reference: SS-273
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 05.07.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

ABX Pentra Precitest Solution

1300017438

IVD generalIVDDOn the market

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230006771
Basic UDI-DI: B-03610230006771
Reference: 1300017438
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 17:00

Manufacturer products View details