Public Access Database for Medical Device Registration

Registration does not represent any form of accreditation, certification or approval by the UK Competent Authority(MHRA)
Where a conformity assessment certificate is listed as expired, existing products already placed on the market prior to the expiry may not be affected by this expiry and can continue to be used. This expiry stops new products being placed on the market until there is a new certificate of conformity

Manufacturer's By Name

By Device

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Manufacturer's Devices - Bergamot Sdn. Bhd.

Address:

N0. 7 & 8 Jalan Sinaran 6 Kawasan Perindustrian Sinaran

Kajang

Selangor 43000

Malaysia

Authorised Representative/ UK Responsible Person
Name: HW Regulatory Ltd
Address:

71-75 Shelton Street Covent Garden

London

WC2H 9JQ

England United Kingdom

Code/Term Type

Nitrile examination/treatment glove non-powdered non-antimicrobial Nitrile examination/treatment glove non-powdered non-antimicrobial Class I

Hevea-latex examination/treatment glove powdered Hevea-latex examination/treatment glove powdered Class I

Hevea-latex examination/treatment glove non-powdered non-antimicrobial Hevea-latex examination/treatment glove non-powdered non-antimicrobial Class I

Vinyl examination/treatment glove non-powdered Vinyl examination/treatment glove non-powdered Class I

Surgical/medical face mask single-use Surgical/medical face mask single-use Class I

Contact details

Freedom of information

0203 080 7272 (manned 10:00-16:00 hours working days) device.registrations@mhra.gov.uk

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Code/Term		Type
Nitrile examination/treatment glove non-powdered non-antimicrobial	Nitrile examination/treatment glove non-powdered non-antimicrobial	Class I
Hevea-latex examination/treatment glove powdered	Hevea-latex examination/treatment glove powdered	Class I
Hevea-latex examination/treatment glove non-powdered non-antimicrobial	Hevea-latex examination/treatment glove non-powdered non-antimicrobial	Class I
Vinyl examination/treatment glove non-powdered	Vinyl examination/treatment glove non-powdered	Class I
Surgical/medical face mask single-use	Surgical/medical face mask single-use	Class I