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171 device results listed.

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IGE TÜRBİDİMETRİK KALİBRATÖR SET

IGE TURBIDIMETRIC CALIBRATOR SET

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08699015281850
Basic UDI-DI: B-08699015281850
Reference: 01R99-01
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 16:13

Manufacturer products View details

HBA1C KALİBRATÖR SET

HBA1C CALIBRATOR SET

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08699015281836
Basic UDI-DI: B-08699015281836
Reference: 01R97-01
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 16:12

Manufacturer products View details

CK-MB KALİBRATÖR

CK-MB CALIBRATOR

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08699015281805
Basic UDI-DI: B-08699015281805
Reference: 01R94-01
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 16:12

Manufacturer products View details

ASO TÜRBİDİMETRİK KALİBRATÖR

ASO TURBIDIMETRIC CALIBRATOR

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08699015281768
Basic UDI-DI: B-08699015281768
Reference: 01R90-01
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 16:12

Manufacturer products View details

MİKROALBÜMİN KALİBRATÖR

MICROALBUMIN CALIBRATOR

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08681812534345
Basic UDI-DI: B-08681812534345
Reference: A301M
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Türkiye
Authorised representative: -
Last updated: 08.07.2026 18:42

Manufacturer products View details

LİPAZ KALİBRATÖR SET

LIPASE CALIBRATOR SET

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08681812530019
Basic UDI-DI: B-08681812530019
Reference: 06R56-03
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Türkiye
Authorised representative: -
Last updated: 08.07.2026 18:41

Manufacturer products View details

ÇİNKO KALİBRATÖR

ZINC CALIBRATOR

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08681812526326
Basic UDI-DI: B-08681812526326
Reference: 06R71-01
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Türkiye
Authorised representative: -
Last updated: 08.07.2026 18:41

Manufacturer products View details

LİPAZ KALİBRATÖR SET

LIPASE CALIBRATOR SET

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08681812526296
Basic UDI-DI: B-08681812526296
Reference: 06R56-01
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Türkiye
Authorised representative: -
Last updated: 08.07.2026 18:41

Manufacturer products View details

RF KALİBRATÖR

RF CALIBRATOR

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08681812526159
Basic UDI-DI: B-08681812526159
Reference: 06T81-69
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Türkiye
Authorised representative: -
Last updated: 08.07.2026 18:40

Manufacturer products View details

DEMİR BAĞLAMA KAPASİTESİ KALİBRATÖR

UIBC CALIBRATOR

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08681812508704
Basic UDI-DI: B-08681812508704
Reference: A301S
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Türkiye
Authorised representative: -
Last updated: 08.07.2026 18:37

Manufacturer products View details

08435287115130

BILIRUBIN STANDARD

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287115130
Basic UDI-DI: B-08435287115130
Reference: 11513
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:46

Manufacturer products View details

HbA1c Calibrator Turbitest AA

IVD generalIVDDNo longer on the marketHuman tissuesProfessional testingReagent

Manufacturer: Wiener Laboratorios SAIC
Manufacturer SRN: AR-MF-000023605
UDI-DI: 07798100040240
Basic UDI-DI: B-07798100040240
Reference: 1999880
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 07:10

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Formed Element Analysis Calibrator

SED-CAL-1

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735362372
Basic UDI-DI: B-06974735362372
Reference: SED-CAL-1
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Formed Element Analysis Calibrator

IVD generalNot specifiedOn the market

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361900
Basic UDI-DI: B-06974735361900
Reference: SED-CAL-1
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Urine Analysis Specific Gravity Calibrator

SG-CAL-Ⅰ

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361542
Basic UDI-DI: B-06974735361542
Reference: SG-CAL-Ⅰ
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Calibrator

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225939069
Basic UDI-DI: B-06971225939069
Reference: HBBZGH
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:30

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Calibrator

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225932251
Basic UDI-DI: B-06971225932251
Reference: HBBZ072
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:24

Manufacturer products Authorised representative products Authorised representative actors View details

MR Urine Standard

IVD Class BNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904026503
Basic UDI-DI: 69449040BA80MRISE******JW
Reference: 105-001690-00
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:11

Manufacturer products Authorised representative products Authorised representative actors View details

MR Urine quality control

IVD Class BNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904026510
Basic UDI-DI: 69449040BA80MRISE******JW
Reference: 105-001691-00
EMDN: W0101050302
EMDN description: URINE CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:11

Manufacturer products Authorised representative products Authorised representative actors View details

β-HB Control

IVD Class BNot specifiedOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904032382
Basic UDI-DI: 69449040004JB-HB*******Q2
Reference: 105-002320-00
EMDN: W0101050302
EMDN description: ENZYME CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details