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 - Kapitex Healthcare Ltd.

Address:

Unit 1 Erivan Park Sandbeck Way

Wetherby

West Yorkshire LS22 7DN

United Kingdom

Serilization:

Authorised Representative
Name: Not Available

Address:

Code/Term Type

Tracheostoma protective filter Class I

Tracheostoma button Class IIb

Tracheostomy tube dressing Class I

Native-tongue assistive training device Class I

Assistive cutlery Class I

Airway device cleaning utensil, noninvasive, reusable Class I

Adult drinking/feeding cup Class I

Tracheostomy tube speech valve Class I

Tracheostomy tube neck holder, reusable Class I

Assistive drinking cup Class I

Wound-nonadherent dressing, absorbent, non-antimicrobial Class I

Synthetic-polymer liquid barrier dressing, non-sterile Class I

Airway device cleaning utensil, invasive Class I

Laryngectomy tube, non-sterile Class IIb

Tracheostoma protector, reusable Class I

Stomal appliance skin-adherent patch, non-sterile Class IIb

Tracheostoma shower shield Class IIb

Airway device cleaning utensil, noninvasive, single-use Class I

Airway device cleaning utensil, noninvasive, single-use Class I

Airway device cleaning utensil, noninvasive, 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
Tracheostoma protective filter		Class I
Tracheostoma button		Class IIb
Tracheostomy tube dressing		Class I
Native-tongue assistive training device		Class I
Assistive cutlery		Class I
Airway device cleaning utensil, noninvasive, reusable		Class I
Adult drinking/feeding cup		Class I
Tracheostomy tube speech valve		Class I
Tracheostomy tube neck holder, reusable		Class I
Assistive drinking cup		Class I
Wound-nonadherent dressing, absorbent, non-antimicrobial		Class I
Synthetic-polymer liquid barrier dressing, non-sterile		Class I
Airway device cleaning utensil, invasive		Class I
Laryngectomy tube, non-sterile		Class IIb
Tracheostoma protector, reusable		Class I
Stomal appliance skin-adherent patch, non-sterile		Class IIb
Tracheostoma shower shield		Class IIb
Airway device cleaning utensil, noninvasive, single-use		Class I
Airway device cleaning utensil, noninvasive, single-use		Class I
Airway device cleaning utensil, noninvasive, single-use		Class I