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 - Mikai S.p.a

Address:

56r

Via Piero Gobetti Genova

GE

Liguria 16145

Italy

Authorised Representative/ UK Responsible Person
Name: Templar Regulatory Consulting Limited
Address:

11 Amor Way

Letchworth Garden City

Hertfordshire SG61UG

England United Kingdom

Code/Term Type

External orthopaedic fixation system single-use External orthopaedic fixation system single-use Class IIb

External orthopaedic fixation system reusable External orthopaedic fixation system reusable Class I

Subtalar implant non-bioabsorbable Subtalar implant non-bioabsorbable Class I

Orthopaedic bone wire Orthopaedic bone wire Class I

Orthopaedic bone screw non-bioabsorbable sterile Orthopaedic bone screw non-bioabsorbable sterile Class IIb

Hand traction plate Hand traction plate Class IIb

Orthopaedic surgical procedure kit non-medicated single-use Orthopaedic surgical procedure kit non-medicated single-use Class IIb

Orthopaedic surgical procedure kit non-medicated single-use Orthopaedic surgical procedure kit non-medicated single-use Class I

Orthopaedic surgical procedure kit non-medicated single-use Orthopaedic surgical procedure kit non-medicated 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
External orthopaedic fixation system single-use	External orthopaedic fixation system single-use	Class IIb
External orthopaedic fixation system reusable	External orthopaedic fixation system reusable	Class I
Subtalar implant non-bioabsorbable	Subtalar implant non-bioabsorbable	Class I
Orthopaedic bone wire	Orthopaedic bone wire	Class I
Orthopaedic bone screw non-bioabsorbable sterile	Orthopaedic bone screw non-bioabsorbable sterile	Class IIb
Hand traction plate	Hand traction plate	Class IIb
Orthopaedic surgical procedure kit non-medicated single-use	Orthopaedic surgical procedure kit non-medicated single-use	Class IIb
Orthopaedic surgical procedure kit non-medicated single-use	Orthopaedic surgical procedure kit non-medicated single-use	Class I
Orthopaedic surgical procedure kit non-medicated single-use	Orthopaedic surgical procedure kit non-medicated single-use	Class I