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Laerdal Pocket Mask

by Laerdal Medical AS 6 variants

Ref 829951Model Pocket Mask

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0704543209950SX Basic UDI-DI 07045430011724UDI-DIDate9 Nov 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number07045430011724 UDI-DI Date20 Oct 2015ListedStatusListed GUDID: not in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Laerdal Pocket Mask EUDAMED
Pocket Mask HC, PL green GUDID
Generic Name
Cardiopulmonary resuscitation mask, reusable
Model / Ref / Catalog
Pocket Mask, 829951
Primary DI / UDI-DI
07045430011724
Basic UDI-DI
0704543209950SX
FDA Product Code
CBP
EMDN Code
R03010199 Ventilation masks - other
GMDN Term
Cardiopulmonary resuscitation mask, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
868.5870
Medical Purpose
The Laerdal Pocket Mask is designed for mouth-to-mask ventilation of a non-breathing adult, child or infant as a barrier between the rescuer and patient. For use on an infant, the mask may be turned 180° to achieve a better seal.
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
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
  • Lot / Batch Number

Other properties (12)

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