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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

Simplex Alternating Cushion 20" x… — Class I MDR

MD Atlas
Meditec Medical Limited

EUDAMED last updated this device on Aug 27, 2025

Simplex Alternating Cushion 20" x 18"

539153749SA001AG

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Meditec Medical Limited
UDI-DI code: 05391537490453
Reference / catalog number: 241162

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Manufacturer information

Organization name: Meditec Medical Limited
SRN: IE-MF-000049210
Manufacturer status: Active

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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.

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW011
Not recommended for patients for whom alternating pressure is contraindicated, such as, but not limited to, unstable spinal cord injury, unstable skeletal fractures requiring immobilisation.
CW014
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Ireland; available across 1 country total.

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

Device identification

Trade name: Simplex Alternating Cushion 20" x 18"
UDI-DI code: 05391537490453
Basic UDI-DI: 539153749SA001AG
Reference / catalog number: 241162
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: 51 MU10
12 MU10
46 MU10

EMDN nomenclature code(s)

V08030101ACTIVE 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
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Software identification