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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Laerdal Medical AS

Certificate 10000470903-PA-NoMA-DNK

Rev. 1Issued
Valid until
Nov 19, 2026

Certificate 10000470903-PA-NoMA-DNK — a Quality management system issued to Laerdal Medical AS — is approaching its expiry. Valid until November 19, 2026. View the full certificate record on MD Atlas.

Overview

Certificate number
10000470903-PA-NoMA-DNK
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
246010000470903-PA-NoMA-DNK1

Validity

Issued
Nov 19, 2021
Valid from
Nov 19, 2021
Valid until
Nov 19, 2026

Manufacturer

Manufacturer
Laerdal Medical AS
Manufacturer SRN
NO-MF-000000012
Manufacturer country
Norway

Notified body

Notified body
DNV Product Assurance AS
Notified body SRN
2460
Notified body country
Norway

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile
No
Human tissues
No
Animal tissues
No
In vitro diagnostics
No
Initial registration
Yes
New device
No
Discard allowed
No
SSCP enabled
Yes
Mechanism of scrutiny
No
Intended medical purpose
No
SPP applicable
No
Conditions applicable
No
MOS outside EUDAMED
—
QMS/MOS type
Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

  • Laerdal Pocket Mask with Oxygen Inlet
    Class IIa
  • 8300xx Pocket Mask with Oxygen Inlet 8300xxxx Pocket Mask with Oxygen Inlet 8310xxxx Pocket Mask with Oxygen Inlet – 100 pack
    Class IIa

Documents

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