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Laerdal Silicone Masks

by Laerdal Medical AS 8 variants

Ref 870221Model Laerdal Silicone 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0704543209946T8 Basic UDI-DI 07045432033946UDI-DIDate15 Nov 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number07045432033946 UDI-DI Date28 Oct 2020ListedStatusListed 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  • Withdrawn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
Laerdal Silicone Masks EUDAMED
Adult Silicone Mask 4-5+ w/o Multi-Func Mask Cover GUDID
Generic Name
Resuscitator face mask, reusable
Model / Ref / Catalog
Laerdal Silicone Mask, 870221
Primary DI / UDI-DI
07045432033946
Basic UDI-DI
0704543209946T8
Direct Marketing DI
07045432033946
FDA Product Code
BYG
EMDN Code
R03010199 Ventilation masks - other
GMDN Term
Resuscitator face mask, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
868.5580
EU market of registration
Norway
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
NO-MF-000000012

Other devices from Laerdal Medical AS

See all devices from Laerdal Medical AS →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (21)

  • 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No