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Bionime Rightest GC300 Glucose Control Solution

GC300

IVD Annex II List BIVDDOn the marketNear-patient testingReagentSelf testing

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: D-GC300RD
Basic UDI-DI: B-GC300RD
Reference: 300G16
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 14.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

Ferritin control

IC0238

IVD generalIVDDOn the marketCompanion diagnosticsHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-FerritinH9
Basic UDI-DI: B-FerritinH9
Reference: IC0238
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 13.07.2026 23:30

Manufacturer products View details

HbA1c Control

FIHBA-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FIHBA-PN20HG5N
Basic UDI-DI: B-FIHBA-PN20HG5N
Reference: FIHBA-PN20
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Control

FIHBA-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FIHBA-PN202R
Basic UDI-DI: B-FIHBA-PN202R
Reference: FIHBA-PN20
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01985119M

Lipid & Immunology Multiple (LIM) Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01985119M
Basic UDI-DI: B-ECH01985119M
Reference: ECH0198511
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01982189L

5′-Nucleotidase (5'-NT) Control

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01982189L
Basic UDI-DI: B-ECH01982189L
Reference: ECH0198218
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01975119E

Lipid & Immunology Multiple (LIM) Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01975119E
Basic UDI-DI: B-ECH01975119E
Reference: ECH0197511
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01972189D

5′-Nucleotidase (5'-NT) Control

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01972189D
Basic UDI-DI: B-ECH01972189D
Reference: ECH0197218
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH019651197

Lipid & Immunology Multiple (LIM) Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH019651197
Basic UDI-DI: B-ECH019651197
Reference: ECH0196511
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH019621896

5′-Nucleotidase (5'-NT) Control

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH019621896
Basic UDI-DI: B-ECH019621896
Reference: ECH0196218
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01961048N

Glycosylated Hemoglobin A1c (HbA1c) Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01961048N
Basic UDI-DI: B-ECH01961048N
Reference: ECH0196104
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH019605694

Cystatin C (Cys C) Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH019605694
Basic UDI-DI: B-ECH019605694
Reference: ECH0196056
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01955118Y

Lipid & Immunology Multiple (LIM) Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01955118Y
Basic UDI-DI: B-ECH01955118Y
Reference: ECH0195511
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH019535192

Homocysteine (Hcy) Control

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH019535192
Basic UDI-DI: B-ECH019535192
Reference: ECH0195351
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01952188X

5′-Nucleotidase (5'-NT) Control

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01952188X
Basic UDI-DI: B-ECH01952188X
Reference: ECH0195218
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01951048F

Glycosylated Hemoglobin A1c (HbA1c) Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01951048F
Basic UDI-DI: B-ECH01951048F
Reference: ECH0195104
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01950608L

Urinary Microalbumin (mAlb) Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01950608L
Basic UDI-DI: B-ECH01950608L
Reference: ECH0195060
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01950568V

Cystatin C (Cys C) Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01950568V
Basic UDI-DI: B-ECH01950568V
Reference: ECH0195056
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01945118R

Lipid & Immunology Multiple (LIM) Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01945118R
Basic UDI-DI: B-ECH01945118R
Reference: ECH0194511
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01942188Q

5′-Nucleotidase (5'-NT) Control

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01942188Q
Basic UDI-DI: B-ECH01942188Q
Reference: ECH0194218
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details