Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, chemiluminescent immunoassay - UK MHRA Medical Device Registration

Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, chemiluminescent immunoassay is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 95014. The device is manufactured by Roche Diagnostics GmbH from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Roche Diagnostics Limited.

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Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, chemiluminescent immunoassay

MHRA Device ID: 95014•Ref: 95014

Device Type

In Vitro Diagnostic Device

Devices

Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, chemiluminescent immunoassay

Type

IVD Annex II List B

Date Registered

Nov 26, 2024

Last Updated

Oct 10, 2024

Manufacturer Information

Name

Roche Diagnostics GmbH

Address

Sandhofer Strasse 116

Mannheim, Germany

Created Date

Apr 19, 2021

Authorized Representative

Name

Roche Diagnostics Limited

Relationship Type

UK Responsible Person

Address

Roche Diagnostics Limited Charles Avenue

Burgess Hill, West Sussex, United Kingdom

Postcode: RH15 9RY

DJ Fang

MedTech Regulatory Expert

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Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, chemiluminescent immunoassay - UK MHRA Medical Device Registration

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