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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

SIT Comfort High — Class I MDR by Bedtime AS

MD Atlas
Bedtime AS

EUDAMED last updated this device on Mar 3, 2026

SIT Comfort High

07072423002391DL

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Bedtime AS
UDI-DI code: 07072423002407
Reference / catalog number: SIT Comfort High

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View device family (Basic UDI)

Manufacturer information

Organization name: Bedtime AS
SRN: NO-MF-000036284
Manufacturer status: Active

Related devices

Bedtime Medical Basic 80x2007072423000001SAOn the market Bedtime Medical Basic 85x2007072423000001SAOn the market Bedtime Medical Basic Mattress7072423000001SAOn the market Bedtime Medical Comfort 80x2007072423000002SCOn the market Bedtime Medical Comfort Mattress7072423000002SCOn 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.

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Norway; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 07072423002407
Basic UDI-DI: 07072423002391DL
Reference / catalog number: SIT Comfort High
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: 24–60 MU10
20–50 MU10

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.

V08030102NON-ACTIVE ANTI-DECUBITUS MEDICAL CUSHIONS

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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