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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

224904 — Class I MDR by SmokeQuit ApS

MD Atlas
SmokeQuit ApS

EUDAMED last updated this device on Mar 15, 2022

224904

57000022242SMOOFF004WW

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SmokeQuit ApS
UDI-DI code: 05700002009081
Reference / catalog number: 224904

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View device family (Basic UDI)

Manufacturer information

Organization name: SmokeQuit ApS
SRN: DK-MF-000019509
Manufacturer status: Active

Critical warnings

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

CW011
Do not leave cigarette with Smooff Extra FilterZeit attached to it on an ash tray. The weight of the product may cause the cigarette to tip off the edge of the ash tray.

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Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Aug 1, 2019	Jan 1, 2022
Austria	Oct 1, 2020	Jan 1, 2022

Device identification

Trade name: not provided
UDI-DI code: 05700002009081
Basic UDI-DI: 57000022242SMOOFF004WW
Reference / catalog number: 224904
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

UDI-DI DataMatrix

Encoded

(01)05700002009081

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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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Related devices

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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.