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Laerdal Silicone Resuscitator

by Laerdal Medical AS Norway EUDAMEDGUDID

Ref 87005240Model LSR Complete w/Masks

Product code BTMEMDN R03020199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0704543209968TJ Basic UDI-DIDate10 Nov 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number07045430046207 UDI-DIDate16 Oct 2015ListedStatusIn distribution

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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Laerdal Silicone Resuscitator EUDAMED
LSR Adult Standard w/Masks in Carton GUDID
Generic Name
Pulmonary resuscitator, manual, reusable
Model / Ref / Catalog
LSR Complete w/Masks, 87005240
Primary DI / UDI-DI
07045430046207
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
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (2)

  • EUDAMED 1c7fecf4-44dc-48ff-ad5b-73714e378798 61 fields · synced 22 Oct 2026
  • FDA UDI 781da857-0b0c-45f4-8b34-70090c353552 36 fields · synced 30 May 2026