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 - IZI Medical Products

Address:

5 Easter Court Suite J

Owings Mills

Maryland 21117

United States

Authorised Representative/ UK Responsible Person
Name: It's Interventional Regulatory Limited
Address:

Albreda House Lydgate Lane

Sheffield

South Yorkshire S10 5FH

England United Kingdom

Code/Term Type

Stereotactic surgery system probe single-use Stereotactic surgery system probe single-use Class IIa

Imaging lesion localization marker external single-use Imaging lesion localization marker external single-use Class IIa

Soft-tissue biopsy procedure kit non-medicated Soft-tissue biopsy procedure kit non-medicated Class IIa

Radiographic image marker manual Radiographic image marker manual Class I

Vertebral body cement-containing implant Vertebral body cement-containing implant Class IIb

Brain biopsy procedure kit Brain biopsy procedure kit Class I

Brain biopsy procedure kit Brain biopsy procedure kit Class IIa

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
Stereotactic surgery system probe single-use	Stereotactic surgery system probe single-use	Class IIa
Imaging lesion localization marker external single-use	Imaging lesion localization marker external single-use	Class IIa
Soft-tissue biopsy procedure kit non-medicated	Soft-tissue biopsy procedure kit non-medicated	Class IIa
Radiographic image marker manual	Radiographic image marker manual	Class I
Vertebral body cement-containing implant	Vertebral body cement-containing implant	Class IIb
Brain biopsy procedure kit	Brain biopsy procedure kit	Class I
Brain biopsy procedure kit	Brain biopsy procedure kit	Class IIa