Skip to content

Laerdal Silicone Resuscitator

by Laerdal Medical AS EUDAMEDGUDID

Active European Union and United States

Ref 86995133Model LSR Complete w/Masks

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0704543209968TJ Basic UDI-DIDate10 Nov 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number07045430045866 UDI-DIDate16 Oct 2015ListedStatusListed

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 25 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID

Trade Name
Laerdal Silicone Resuscitator EUDAMED
LSR Paediatric Cpl w/Masks in Carton (IE) PL GUDID
Generic Name
Pulmonary resuscitator, manual, reusable
Model / Ref / Catalog
LSR Complete w/Masks, 86995133
Primary DI / UDI-DI
07045430045866
Basic UDI-DI
0704543209968TJ
FDA Product Code
BTM
EMDN Code
R03020199 Ventilation balloons - other
GMDN Term
Pulmonary resuscitator, manual, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
868.5915
Medical Purpose
The Laerdal Silicone Resuscitator (LSR) is intended for patients requiring total or intermittent ventilatory support. Ventilation is possible with or without supplemental oxygen. The Laerdal Silicone Resuscitator is available in three sizes: • The Adult model is intended for patients over 25 kg (44 lb). • The Paediatric model is intended for patients from 2.5 kg (5.5 lb) to 25 kg (44 lb). • The Preterm model is intended for patients below 2.5 kg (5.5 lb).
Commercial Distribution
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
NO-PR-000002650

Other devices from Laerdal Medical AS

See all devices from Laerdal Medical AS →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No