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Laerdal Pediatric Pocket Mask

by Laerdal Medical AS 4 variants

Ref 820053Model Paediatric Pocket Mask

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

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 Number0704543209938T9 Basic UDI-DI 07045430078673UDI-DIDate14 Nov 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number07045430078673 UDI-DI Date19 Oct 2015ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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 Pediatric Pocket Mask EUDAMED
Paed. PM w/o wipe and gloves CPR Barrier Dev. GUDID
Generic Name
Cardiopulmonary resuscitation mask, single-use
Model / Ref / Catalog
Paediatric Pocket Mask, 820053
Primary DI / UDI-DI
07045430078673
Basic UDI-DI
0704543209938T9
Direct Marketing DI
07045430078673
510(k) Number
FDA Product Code
CBP
EMDN Code
R03010199 Ventilation masks - other
GMDN Term
Cardiopulmonary resuscitation mask, single-use
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

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (21)

  • Sterile: 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