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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

8000201-2 — Class I MDR by ComfortSystem…

MD Atlas
ComfortSystem Scandinavia AB

EUDAMED last updated this device on May 21, 2026

8000201-2

735000589TCRL

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ComfortSystem Scandinavia AB
UDI-DI code: 07350005891336
Reference / catalog number: 8000201-2

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View device family (Basic UDI)

Manufacturer information

Organization name: ComfortSystem Scandinavia AB
SRN: SE-MF-000038482
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Sweden; available across 2 countries total.

Country	On market since	Until
SwedenPrimary placement	Mar 1, 2021	Still on market
Norway	Mar 1, 2021	Still on market

Device identification

Trade name: not provided
UDI-DI code: 07350005891336
Basic UDI-DI: 735000589TCRL
Reference / catalog number: 8000201-2
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: Stödhandtag avsett för Comfortabel sängryggstöd
Additional information URL: https://www.comfortsystem.se/se/bruksanvisningar/sangryggstod/
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)07350005891336

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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.

V08068002BED SUPPORTS

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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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.