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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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Organization name
UDI-DI code
Reference / catalog number

46000211 — Class I MDR by Laerdal Medical AS

MD Atlas
Laerdal Medical AS

EUDAMED last updated this device on Jan 8, 2025

46000211

0704543209941SW

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Laerdal Medical AS
UDI-DI code: 07045432116960
Reference / catalog number: 46000211

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View device family (Basic UDI)

Manufacturer information

Organization name: Laerdal Medical AS
SRN: NO-MF-000000012
Manufacturer status: Active

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Certificates

Certificate health across this manufacturer's portfolio.

10000470903-PA-NoMA-DNKIssued
Quality management systemNotified body: 2460Expiry: Nov 19, 2026

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW018
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Denmark; available across 1 country total.

Placed on the market in Denmark; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 07045432116960
Basic UDI-DI: 0704543209941SW
Reference / catalog number: 46000211
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

R03010199VENTILATION MASKS - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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