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08809446080704

BGT-N05082

IVD generalIVDDOn the marketHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: WELLS BIO, INC.
Manufacturer SRN: KR-MF-000031789
UDI-DI: 08809446080704
Basic UDI-DI: B-08809446080704
Reference: BGT-N05082
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Belgium
Authorised representative: MDSS GmbH
Last updated: 10.07.2026 14:09

Manufacturer products Authorised representative products Authorised representative actors View details

08809446080698

BGO-N05082

IVD generalIVDDOn the marketHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: WELLS BIO, INC.
Manufacturer SRN: KR-MF-000031789
UDI-DI: 08809446080698
Basic UDI-DI: B-08809446080698
Reference: BGO-N05082
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Belgium
Authorised representative: MDSS GmbH
Last updated: 10.07.2026 14:09

Manufacturer products Authorised representative products Authorised representative actors View details

GREENCARE LIPID Control Solution

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testing

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134663317
Basic UDI-DI: B-08806134663317
Reference: 0633C10
EMDN: W0101050202
EMDN description: LIPID CONTROLS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

CERA-CHEK™ 3 in 1 GHL Lactate Control Solution

M 400

IVD Annex II List BIVDDOn the marketNear-patient testingSelf testing

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065181209
Basic UDI-DI: B-08800065181209
Reference: M400C12
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

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

CERA-CHEK™ 3 in 1 GHL Glucose Control Solution

M 400

IVD Annex II List BIVDDOn the marketNear-patient testingSelf testing

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065181001
Basic UDI-DI: B-08800065181001
Reference: M400C10
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
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

CERA-STAT™ HbA1c Control Solution

CS 4000

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testingReagent

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065178001
Basic UDI-DI: B-08800065178001
Reference: CS400C10
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
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

CERA-STAT™ 2000 HbA1c Control Solution

CS 2000

IVD generalIVDDNo longer on the marketNear-patient testingProfessional testing

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065176007
Basic UDI-DI: B-08800065176007
Reference: CS200C10
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
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

CERA-CHEK™ 1Code Glucose Control Solution

G 400

IVD Annex II List BIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065174003
Basic UDI-DI: B-08800065174003
Reference: G400C10
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

CERA-CHEK™ 1070 Glucose Control Solution

G 300

IVD Annex II List BIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065172009
Basic UDI-DI: B-08800065172009
Reference: G300C10
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

LabonaCheck™ A1c Control Solution

MH 200

IVD generalIVDDNo longer on the marketNear-patient testingProfessional testing

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065168002
Basic UDI-DI: B-08800065168002
Reference: MH200C10
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
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

HBA1C KONTROL SET

HBA1C CONTROL SET

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08699015281829
Basic UDI-DI: B-08699015281829
Reference: 01R96-01
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 16:12

Manufacturer products View details

CK-MB KONTROL SEVİYE II

CK-MB CONTROL LEVEL II

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08699015281799
Basic UDI-DI: B-08699015281799
Reference: 01R93-01
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 16:12

Manufacturer products View details

CK-MB KONTROL SEVİYE I

CK-MB CONTROL LEVEL I

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08699015281782
Basic UDI-DI: B-08699015281782
Reference: 01R92-01
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 16:12

Manufacturer products View details

URINARY PROTEIN Kit

URINARY PROTEIN Kit 224mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000040334
UDI-DI: 08683555616289
Basic UDI-DI: B-08683555616289
Reference: B33300
EMDN: W0101050207
EMDN description: URINE CONTROLS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 00:43

Manufacturer products View details

MİKROALBÜMİN KONTROL

MICROALBUMIN CONTROL

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08681812534383
Basic UDI-DI: B-08681812534383
Reference: A302M
EMDN: W0101050207
EMDN description: URINE CONTROLS
First on market country: Türkiye
Authorised representative: -
Last updated: 08.07.2026 18:42

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