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Isol/8

by Isol8 Healthcare Ltd EUDAMED

Active European Union

Ref IS8S05, IS8HB03W, IS8WJ02, IS8E27, IS8PG01, IS8HB01, IS8WJS03, IS8HC03, IS8E13, IS8E14, IS8HC01, IS8HB02, IS8E26, IS8E12, IS8E04, IS8RM02P, IS8HB04W, IS8E09, IS8S04, IS8E11, IS8E10, IS8HB06G, IS8P05, IS8RM01P, IS8HB01G, IS8E21, IS8P03, IS8HB02Y, IS8E05, IS8HC04, IS8HB05G, IS8S06, IS8P06, IS8E06, IS8HB06W, IS8RM02S, IS8E23, IS8PG02, IS8P04, IS8HB03, IS8P07, IS8SC01, IS8HB03G, IS8WJS01Model ISOL/8 Supreme Impervious Surgical Gown XXL-Long, ISOL/8 Theatre Headwear (Comfort and Basics Ranges), Warming Jackets, ISOL/8 Elemental Light Standard Surgical Gown XXXL, ISOL/8 Short-Sleeved Patient Examination Gowns, ISOL/8 Elemental Poly-reinforced Surgical Gown XXL-Long, ISOL/8 Elemental Poly-reinforced Surgical Gown XXXL, ISOL/8 Elemental Light Standard Surgical Gown XXL-Long, ISOL/8 Elemental Poly-reinforced Surgical Gown XXL, ISOL/8 Elemental Standard Surgical Gown XL-Long, FLUIDSAFE Surgical Mask, ISOL/8 Elemental Poly-reinforced Surgical Gown L, ISOL/8 Supreme Impervious Surgical Gown XXL, ISOL/8 Elemental Poly-reinforced Surgical Gown XL-Long, ISOL/8 Elemental Poly-reinforced Surgical Gown XL, ISOL/8 Plush Standard Surgical Gown XXL, ISOL/8 Elemental Light Standard Surgical Gown M, ISOL/8 Plush Standard Surgical Gown XL, ISOL/8 Elemental Standard Surgical Gown XXL, ISOL/8 Supreme Impervious Surgical Gown XXXL, ISOL/8 Plush Standard Surgical Gown XXL-Long, ISOL/8 Elemental Standard Surgical Gown XXL-Long, ISOL/8 Elemental Light Standard Surgical Gown XL, ISOL/8 Plush Standard Surgical Gown XL-Long, ISOL/8 Plush Standard Surgical Gown XXXL, ISOL/8 Shoe Covers

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-05391541270263 Basic UDI-DIDate25 Jun 2025RegisteredStatusActive
European UnionCE/MDD NumberB-05391541270263 Basic UDI-DIDate25 Jun 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR, CE/MDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Surgical Gown
Theatre Headwear
Warming Jackets
Patient Gown
Surgical Face Mask
Shoe Covers
Model / Reference
ISOL/8 Supreme Impervious Surgical Gown XXL-Long, IS8S05, ISOL/8 Theatre Headwear (Comfort and Basics Ranges), IS8HB03W, Warming Jackets, IS8WJ02, ISOL/8 Elemental Light Standard Surgical Gown XXXL, IS8E27, ISOL/8 Short-Sleeved Patient Examination Gowns, IS8PG01, IS8HB01, IS8WJS03, IS8HC03, ISOL/8 Elemental Poly-reinforced Surgical Gown XXL-Long, IS8E13, ISOL/8 Elemental Poly-reinforced Surgical Gown XXXL, IS8E14, IS8HC01, IS8HB02, ISOL/8 Elemental Light Standard Surgical Gown XXL-Long, IS8E26, ISOL/8 Elemental Poly-reinforced Surgical Gown XXL, IS8E12, ISOL/8 Elemental Standard Surgical Gown XL-Long, IS8E04, FLUIDSAFE Surgical Mask, IS8RM02P, IS8HB04W, ISOL/8 Elemental Poly-reinforced Surgical Gown L, IS8E09, ISOL/8 Supreme Impervious Surgical Gown XXL, IS8S04, ISOL/8 Elemental Poly-reinforced Surgical Gown XL-Long, IS8E11, ISOL/8 Elemental Poly-reinforced Surgical Gown XL, IS8E10, IS8HB06G, ISOL/8 Plush Standard Surgical Gown XXL, IS8P05, IS8RM01P, IS8HB01G, ISOL/8 Elemental Light Standard Surgical Gown M, IS8E21, ISOL/8 Plush Standard Surgical Gown XL, IS8P03, IS8HB02Y, ISOL/8 Elemental Standard Surgical Gown XXL, IS8E05, IS8HC04, IS8HB05G, ISOL/8 Supreme Impervious Surgical Gown XXXL, IS8S06, ISOL/8 Plush Standard Surgical Gown XXL-Long, IS8P06, ISOL/8 Elemental Standard Surgical Gown XXL-Long, IS8E06, IS8HB06W, IS8RM02S, ISOL/8 Elemental Light Standard Surgical Gown XL, IS8E23, IS8PG02, ISOL/8 Plush Standard Surgical Gown XL-Long, IS8P04, IS8HB03, ISOL/8 Plush Standard Surgical Gown XXXL, IS8P07, ISOL/8 Shoe Covers, IS8SC01, IS8HB03G, IS8WJS01
Primary DI / UDI-DI
05391541270263, 05391541272670, 05391541270478, 05391541271741, 05391541270515, 05391541270409, 05391541271468, 05391541270379, 05391541270133, 05391541270140, 05391541270355, 05391541270416, 05391541271734, 05391541270126, 05391541270041, 05391541270300, 05391541272731, 05391541270096, 05391541270256, 05391541270119, 05391541270102, 05391541272878, 05391541270195, 05391541270287, 05391541272571, 05391541271697, 05391541270171, 05391541272656, 05391541270058, 05391541270386, 05391541272816, 05391541270270, 05391541270201, 05391541270065, 05391541272854, 05391541270294, 05391541271703, 05391541270522, 05391541270188, 05391541270423, 05391541270218, 05391541271079, 05391541272694, 05391541271444
Basic UDI-DI
B-05391541270263, 539154127IS8THC6, 539154127IS8TCBU, B-05391541271741, 539154127IS8PGBQ, B-05391541270133, B-05391541270140, B-05391541271734, B-05391541270126, B-05391541270041, 0539154127IS8SMXG, B-05391541270096, B-05391541270256, B-05391541270119, B-05391541270102, B-05391541270195, B-05391541271697, B-05391541270171, B-05391541270058, B-05391541270270, B-05391541270201, B-05391541270065, B-05391541271703, B-05391541270188, B-05391541270218, 539154127IS8SCBR
EMDN Code
T020499, T0207, T0299, T020401, T0205, T020402, T020604, T0208
Device Class
Class I
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000012420

From the manufacturer

Manufacturer's product page: ISOL8 Healthcare Awarded onto NHS Supply Chain Framework for Blood Collection Devices

Other devices from Isol8 Healthcare Ltd

See all devices from Isol8 Healthcare Ltd →

Properties

  • Sterile YesEUDAMEDNoEUDAMED

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No