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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

3971 W — Class I MDR by JedX Medcare

MD Atlas
JedX Medcare

EUDAMED last updated this device on Oct 13, 2023

3971 W

64298103813971WQK

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: JedX Medcare
UDI-DI code: 06429810381507
Reference / catalog number: 3971 W

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Manufacturer information

Organization name: JedX Medcare
SRN: FI-MF-000033367
Manufacturer status: Active

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Finland; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 06429810381507
Basic UDI-DI: 64298103813971WQK
Reference / catalog number: 3971 W
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: Tuote on kertakäyttöinen roiskeilta suojaava hengityssuojain.Tuotteen käyttötarkoitus lääkinnällisenä laitteena on vähentää käyttäjästään muille henkilöille siirtyvien haitallisten partikkeleiden ja pisaroiden siirtymistä.
Additional information URL: No additional information URL provided by the manufacturer.
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

Related devices

3614 PW64298103813614WPNPOn the market 3805 PW64298103813805WPPBOn the market 3972 W64298103813972WQNOn the market 1351 W64298103811351WN9On the market

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.