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The Laerdal Pocket Mask

by Laerdal Medical AS 2 variants

Ref 82000633Model Laerdal Pocket Mask

Active European Union. Also listed in GUDID (US).

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0704543209939TB Basic UDI-DI 07045430011472UDI-DIDate17 Nov 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number07045430011472 UDI-DI Date20 Oct 2015ListedStatusListed GUDID: 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  • Withdrawn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
The Laerdal Pocket Mask EUDAMED
Pocket Mask,PB(IE) GUDID
Generic Name
Cardiopulmonary resuscitation mask, reusable
Device Name
Laerdal Pocket Mask
Model / Ref / Catalog
Laerdal Pocket Mask, 82000633
Primary DI / UDI-DI
07045430011472
Basic UDI-DI
0704543209939TB
Direct Marketing DI
07045430011472
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
EU market of registration
Norway
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
NO-MF-000000012

Other devices from Laerdal Medical AS

See all devices from Laerdal Medical AS →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • 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
  • 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