United Kingdom MHRA device registration 204909

Anti-Mullerian hormone (AMH) IVD, kit, chemiluminescent immunoassay

United Kingdom·In Vitro Diagnostic Device·Accucise Diagnostics Inc.·Registered Nov 26, 2024

Registration details

Device ID: 204909
MHRA Reference Number: 204909
Date Registered: Nov 26, 2024
Last Updated: Nov 14, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Anti-Mullerian hormone (AMH) IVD, kit, chemiluminescent immunoassay
Type: IVD General

Manufacturer

Name: Accucise Diagnostics Inc.
Address: Suite 501&601, Building 9, Medpark, 188 Fuchunjiang Rd., SND
Suzhou Province, China
Created Date: Nov 8, 2024

Authorized Representative

Name: SUNGO Certification Company Limited
Relationship Type: UK Responsible Person
Address: 3rd Floor, 70 Gracechurch Street
London, England, United Kingdom
Postcode: EC3V 0HR

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About this record

Anti-Mullerian hormone (AMH) IVD, kit, chemiluminescent immunoassay is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 204909. The device is manufactured by Accucise Diagnostics Inc. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is SUNGO Certification Company Limited.

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