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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

400 — Class I MDR by 4N Health Oy Ltd

MD Atlas
4N Health Oy Ltd

EUDAMED last updated this device on Nov 26, 2021

400

64298300663KeepsafeQT

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: 4N Health Oy Ltd
UDI-DI code: 06429830066316
Reference / catalog number: 400

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Manufacturer information

Organization name: 4N Health Oy Ltd
SRN: FI-MF-000004502
Manufacturer status: Active

Market distribution

Primary placement in Finland; available across 2 countries total.

Country	On market since	Until
FinlandPrimary placement	Jun 30, 2020	Still on market
Denmark	Jul 30, 2020	Still on market

Device identification

Trade name: not provided
UDI-DI code: 06429830066316
Basic UDI-DI: 64298300663KeepsafeQT
Reference / catalog number: 400
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: https://keepsafe.fi/en/faq/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T020604MEDICAL USE FACE MASKS, TYPE II AND IIR

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.