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Isol8 Healthcare Ltd

Active in EUDAMED

Irelandfrom SRN EUDAMED SRN IE-MF-000012420

Devices
41
Registrations
EUDAMED

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor

Catalogue41

  • Isol/8 Ref IS8S03

    Class I EUDAMED Active
  • Isol/8 Ref IS8HB05Y

    Class I EUDAMED Active
  • Isol/8 Ref IS8SG01

    Class I EUDAMED Active
  • Isol/8 Ref IS8P02

    Class I EUDAMED Active
  • Isol/8 Ref IS8HB02W

    Class I EUDAMED Active
  • Isol/8 Ref IS8E01

    Class I EUDAMED Active
  • Isol/8 Ref IS8HB02G

    Class I EUDAMED Active
  • Isol/8 Ref IS8HB05W

    Class I EUDAMED Active
  • Isol/8 Ref IS8E24

    Class I EUDAMED Active
  • Isol/8 Ref IS8E22

    Class I EUDAMED Active
  • Isol/8 Ref IS8HB04

    Class I EUDAMED Active
  • Isol/8 Ref IS8SG02

    Class I EUDAMED Active
  • Isol/8 Ref IS8RM03P

    Class I EUDAMED Active
  • Isol/8 Ref IS8HB01Y

    Class I EUDAMED Active
  • Isol/8 Ref IS8HB04Y

    Class I EUDAMED Active
  • Isol/8 Ref IS8HC05

    Class I EUDAMED Active
  • Isol/8 Ref IS8E25

    Class I EUDAMED Active
  • Isol/8 Ref IS8HC02

    Class I EUDAMED Active
  • Isol/8 Ref IS8HB03Y

    Class I EUDAMED Active
  • Isol/8 Ref IS8SC02

    Class I EUDAMED Active
  • Isol/8 Ref IS8S01

    Class I EUDAMED Active
  • Isol/8 Ref IS8E08

    Class I EUDAMED Active
  • Isol/8 Ref IS8HB01W

    Class I EUDAMED Active
  • Isol/8 Ref IS8P01

    Class I EUDAMED Active
  • Isol/8 Ref IS8RM04P

    Class I EUDAMED Active
  • Isol/8 Ref IS8WJS02

    Class I EUDAMED Active
  • Isol/8 Ref IS8WJ01

    Class I EUDAMED Active
  • Isol/8 Ref IS8E03

    Class I EUDAMED Active
  • Isol/8 Ref IS8RM03S

    Class I EUDAMED Active
  • Isol/8 Ref IS8HB06

    Class I EUDAMED Active
  • Isol/8 Ref IS8HB05

    Class I EUDAMED Active
  • Isol/8 Ref IS8S02

    Class I EUDAMED Active
  • Isol/8 Ref IS8HB06Y

    Class I EUDAMED Active
  • Isol/8 Ref IS8SC03

    Class I EUDAMED Active
  • Isol/8 Ref IS8RM04S

    Class I EUDAMED Active
  • Isol/8 Ref IS8RM01S

    Class I EUDAMED Active
  • Isol/8 Ref IS8HB04G

    Class I EUDAMED Active
  • Isol/8 Ref IS8HB07

    Class I EUDAMED Active
  • Isol/8 Ref IS8S05

    Class I EUDAMED Active
  • Isol/8 Ref IS8E07

    Class I EUDAMED Active
  • Isol/8 Ref IS8E02

    Class I EUDAMED Active

Company details

EUDAMED SRN
IE-MF-000012420
EU VAT number
IE3751058DH
EUDAMED status
Active
EUDAMED registered name
Isol8 Healthcare Ltd
Registered address
Unit 4 Joyce House, P31 HW35, Ballincollig, Co. Cork, Ireland
Phone
+353 667121659
PRRC contact
Fergal Whitehead(public in EUDAMED)

From the company website

Read 18 Sep 2026

ISOL8 Healthcare is a leading manufacturer of surgical gowns and other medical consumables, focused on the best quality and value for money.

From the manufacturer's own website. Source

What Isol8 Healthcare Ltd makes

Isol8 Healthcare Ltd manufactures reusable surgical gowns designed for single-use applications in healthcare settings. These gowns are intended to provide barrier protection for medical personnel during surgical procedures and other clinical interventions.

The company’s products are classified as Class I medical devices and are registered in the EU via the eudamed database. The manufacturer is based in Ireland.

AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.

Frequently asked questions

How many devices does Isol8 Healthcare Ltd have in the registry?

The registry currently lists 41 devices for Isol8 Healthcare Ltd. Devices recorded under merged duplicate company entries are counted once.

Which registries list Isol8 Healthcare Ltd's devices?

Among its 41 most recently registered devices, Isol8 Healthcare Ltd has devices listed in EUDAMED (41 devices).

What risk classes do Isol8 Healthcare Ltd's devices fall under?

Among its 41 most recently registered devices, the classes recorded for Isol8 Healthcare Ltd's devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from Isol8 Healthcare Ltd in the registry?

The most recently registered devices listed for Isol8 Healthcare Ltd include ISOL/8.

Generated automatically from registry data and not verified by a human reviewer.