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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

Chest foam strap — Class I MDR by DANISH HEALTHCARE ApS

MD Atlas
DANISH HEALTHCARE ApS

EUDAMED last updated this device on Apr 8, 2026

Chest foam strap

5715005000515Y

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: DANISH HEALTHCARE ApS
UDI-DI code: 05715005010514
Reference / catalog number: 5004

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Manufacturer information

Organization name: DANISH HEALTHCARE ApS
SRN: DK-MF-000001741
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 Denmark; available across 1 country total.

Country	On market since	Until
DenmarkPrimary placement		Still on market

Device identification

Trade name: Chest foam strap
UDI-DI code: 05715005010514
Basic UDI-DI: 5715005000515Y
Reference / catalog number: 5004
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: The positioning systems intended use, is to fixate the patient firmly on the operating table
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V080302PATIENT POSITIONING 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

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.