EUDAMED update: Aug 14, 2024

Genedrive Diagnostics Ltd.

GB-MF-000012810

Active38 devices

Address: Grafton Street, 48 M139XX Manchester
Role: Manufacturer
Date of registration: Sep 7, 2021
Country: United Kingdom

Genedrive Diagnostics Ltd. is a medical device manufacturer registered in EUDAMED. The company has 38 devices on the EU market across 10 countries. It holds 2 valid CE certificates. Headquartered in Manchester, United Kingdom. Explore the regulatory profile, devices and certificates on MD Atlas.

About Genedrive Diagnostics Ltd.

: GB-MF-000012810
Role: Manufacturer
Country: United Kingdom
Organization name: Genedrive Diagnostics Ltd.
EU VAT number: 903 0350 77
EORI: GB903035077000
Trade register: Companies House
Date of registration: Sep 7, 2021

Contact details for Genedrive Diagnostics Ltd.

Phone: +44 (0) 161 989 0240
Email: c.alexander@genedrive.com
Website: www.genedrive.com
Address: 48, GRAFTON STREET M139XX MANCHESTER UNITED KINGDOM

Competent authority

Name: Malta Medicines Authority

Phone: +356 23439000
Email: devices.medicinesauthority@gov.mt

Officers and regulatory representatives of Genedrive Diagnostics Ltd.

ALEXANDER Caroline
Quality Assurance, Regulatory Compliance
Hidden

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
Genedrive® CYP2C19 Control Kit	Genedrive® CYP2C19 Control Kit	`CYP2C19-CTRL10-DE`	`05060654860646`	10	On the market
Genedrive® CYP2C19 Control Kit	Genedrive® CYP2C19 Control Kit	`CYP2C19-CTRL10-NL`	`05060654860608`	10	On the market
Genedrive® CYP2C19 Control Kit	Genedrive® CYP2C19 Control Kit	`CYP2C19-CTRL10-TR`	`05060654860660`	10	On the market
Genedrive® CYP2C19 Control Kit	Genedrive® CYP2C19 Control Kit	`CYP2C19-CTRL10-PT`	`05060654860653`	10	On the market
Genedrive® System	Genedrive® System	`GS-002 V6.0`	`05060654860417`	1	On the market
Genedrive® CYP2C19 Collection Kit	Genedrive® CYP2C19 Collection Kit	`CK-CYP2C19-10`	`05060654860752`	10	On the market
Genedrive® CYP2C19 Collection Kit	Genedrive® CYP2C19 Collection Kit	`CK-CYP2C19-10-FR`	`05060654860769`	10	On the market
Genedrive® CYP2C19 Collection Kit	Genedrive® CYP2C19 Collection Kit	`CK-CYP2C19-10-DE`	`05060654860813`	10	On the market
Genedrive® CYP2C19 Collection Kit	Genedrive® CYP2C19 Collection Kit	`CK-CYP2C19-10-EL`	`05060654860806`	10	On the market
Genedrive® CYP2C19 Collection Kit	Genedrive® CYP2C19 Collection Kit	`CK-CYP2C19-10-PT`	`05060654860820`	10	On the market
Genedrive® CYP2C19 Collection Kit	Genedrive® CYP2C19 Collection Kit	`CK-CYP2C19-10-PL`	`05060654860868`	10	On the market
Genedrive® CYP2C19 Collection Kit	Genedrive® CYP2C19 Collection Kit	`CK-CYP2C19-10-IT`	`05060654860790`	10	On the market
Genedrive® CYP2C19 Collection Kit	Genedrive® CYP2C19 Collection Kit	`CK-CYP2C19-10-NL`	`05060654860776`	10	On the market
Genedrive® CYP2C19 Collection Kit	Genedrive® CYP2C19 Collection Kit	`CK-CYP2C19-10-TR`	`05060654860837`	10	On the market
Genedrive® CYP2C19 Collection Kit	Genedrive® CYP2C19 Collection Kit	`CK-CYP2C19-10-ES`	`05060654860783`	10	On the market
Genedrive® CYP2C19 Control Kit	Genedrive® CYP2C19 Control Kit	`CYP2C19-CTRL10-EL`	`05060654860639`	10	On the market
Genedrive® CYP2C19 Control Kit	Genedrive® CYP2C19 Control Kit	`CYP2C19-CTRL10-PL`	`05060654860851`	10	On the market
Genedrive® CYP2C19 Control Kit	Genedrive® CYP2C19 Control Kit	`CYP2C19-CTRL10`	`05060654860585`	10	On the market
Genedrive® CYP2C19 Control Kit	Genedrive® CYP2C19 Control Kit	`CYP2C19-CTRL10-FR`	`05060654860592`	10	On the market
Genedrive® CYP2C19 Control Kit	Genedrive® CYP2C19 Control Kit	`CYP2C19-CTRL10-ES`	`05060654860615`	10	On the market
Genedrive® CYP2C19 Control Kit	Genedrive® CYP2C19 Control Kit	`CYP2C19-CTRL10-IT`	`05060654860622`	10	On the market
Genedrive® CYP2C19 ID Kit	Genedrive® CYP2C19 ID Kit	`ID-CYP2C19-10-DE`	`05060654860547`	10	On the market
Genedrive® CYP2C19 ID Kit	Genedrive® CYP2C19 ID Kit	`ID-CYP2C19-10-EL`	`05060654860530`	10	On the market
Genedrive® CYP2C19 ID Kit	Genedrive® CYP2C19 ID Kit	`ID-CYP2C19-10-IT`	`05060654860523`	10	On the market
Genedrive® CYP2C19 ID Kit	Genedrive® CYP2C19 ID Kit	`ID-CYP2C19-10-FR`	`05060654860493`	10	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
Genedrive® CYP2C19 Control Kit	Genedrive® CYP2C19 Control Kit	`CYP2C19-CTRL10-DE`	`05060654860646`	10	On the market
Genedrive® CYP2C19 Control Kit	Genedrive® CYP2C19 Control Kit	`CYP2C19-CTRL10-NL`	`05060654860608`	10	On the market
Genedrive® CYP2C19 Control Kit	Genedrive® CYP2C19 Control Kit	`CYP2C19-CTRL10-TR`	`05060654860660`	10	On the market
Genedrive® CYP2C19 Control Kit	Genedrive® CYP2C19 Control Kit	`CYP2C19-CTRL10-PT`	`05060654860653`	10	On the market
Genedrive® System	Genedrive® System	`GS-002 V6.0`	`05060654860417`	1	On the market
Genedrive® CYP2C19 Collection Kit	Genedrive® CYP2C19 Collection Kit	`CK-CYP2C19-10`	`05060654860752`	10	On the market
Genedrive® CYP2C19 Collection Kit	Genedrive® CYP2C19 Collection Kit	`CK-CYP2C19-10-FR`	`05060654860769`	10	On the market
Genedrive® CYP2C19 Collection Kit	Genedrive® CYP2C19 Collection Kit	`CK-CYP2C19-10-DE`	`05060654860813`	10	On the market
Genedrive® CYP2C19 Collection Kit	Genedrive® CYP2C19 Collection Kit	`CK-CYP2C19-10-EL`	`05060654860806`	10	On the market
Genedrive® CYP2C19 Collection Kit	Genedrive® CYP2C19 Collection Kit	`CK-CYP2C19-10-PT`	`05060654860820`	10	On the market
Genedrive® CYP2C19 Collection Kit	Genedrive® CYP2C19 Collection Kit	`CK-CYP2C19-10-PL`	`05060654860868`	10	On the market
Genedrive® CYP2C19 Collection Kit	Genedrive® CYP2C19 Collection Kit	`CK-CYP2C19-10-IT`	`05060654860790`	10	On the market
Genedrive® CYP2C19 Collection Kit	Genedrive® CYP2C19 Collection Kit	`CK-CYP2C19-10-NL`	`05060654860776`	10	On the market
Genedrive® CYP2C19 Collection Kit	Genedrive® CYP2C19 Collection Kit	`CK-CYP2C19-10-TR`	`05060654860837`	10	On the market
Genedrive® CYP2C19 Collection Kit	Genedrive® CYP2C19 Collection Kit	`CK-CYP2C19-10-ES`	`05060654860783`	10	On the market
Genedrive® CYP2C19 Control Kit	Genedrive® CYP2C19 Control Kit	`CYP2C19-CTRL10-EL`	`05060654860639`	10	On the market
Genedrive® CYP2C19 Control Kit	Genedrive® CYP2C19 Control Kit	`CYP2C19-CTRL10-PL`	`05060654860851`	10	On the market
Genedrive® CYP2C19 Control Kit	Genedrive® CYP2C19 Control Kit	`CYP2C19-CTRL10`	`05060654860585`	10	On the market
Genedrive® CYP2C19 Control Kit	Genedrive® CYP2C19 Control Kit	`CYP2C19-CTRL10-FR`	`05060654860592`	10	On the market
Genedrive® CYP2C19 Control Kit	Genedrive® CYP2C19 Control Kit	`CYP2C19-CTRL10-ES`	`05060654860615`	10	On the market
Genedrive® CYP2C19 Control Kit	Genedrive® CYP2C19 Control Kit	`CYP2C19-CTRL10-IT`	`05060654860622`	10	On the market
Genedrive® CYP2C19 ID Kit	Genedrive® CYP2C19 ID Kit	`ID-CYP2C19-10-DE`	`05060654860547`	10	On the market
Genedrive® CYP2C19 ID Kit	Genedrive® CYP2C19 ID Kit	`ID-CYP2C19-10-EL`	`05060654860530`	10	On the market
Genedrive® CYP2C19 ID Kit	Genedrive® CYP2C19 ID Kit	`ID-CYP2C19-10-IT`	`05060654860523`	10	On the market
Genedrive® CYP2C19 ID Kit	Genedrive® CYP2C19 ID Kit	`ID-CYP2C19-10-FR`	`05060654860493`	10	On the market

Genedrive Diagnostics Ltd.

About Genedrive Diagnostics Ltd.

Contact details for Genedrive Diagnostics Ltd.

Competent authority

Officers and regulatory representatives of Genedrive Diagnostics Ltd.

Related searches

About Genedrive Diagnostics Ltd.

Contact details for Genedrive Diagnostics Ltd.

Competent authority

Officers and regulatory representatives of Genedrive Diagnostics Ltd.

Statistics for Genedrive Diagnostics Ltd.

Certificate health for Genedrive Diagnostics Ltd.

Issuing notified bodies

Related documents

Devices by risk class

Device catalog for Genedrive Diagnostics Ltd.

Device families (Basic UDI-DI) of Genedrive Diagnostics Ltd.

Market presence of Genedrive Diagnostics Ltd.

Connected operators

Importers

Authorised representatives

Related searches

Market presence of Genedrive Diagnostics Ltd.

Devices by risk class

Issuing notified bodies

Device families (Basic UDI-DI) of Genedrive Diagnostics Ltd.

Statistics for Genedrive Diagnostics Ltd.

Certificate health for Genedrive Diagnostics Ltd.

Connected operators

Importers

Authorised representatives

Related documents

Device catalog for Genedrive Diagnostics Ltd.