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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

PQ2K021P01 — Class I MDR by PRIME Medical Solutions

MD Atlas
PRIME Medical Solutions

EUDAMED last updated this device on May 22, 2026

PQ2K021P01

540701054Q2K02TT

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PRIME Medical Solutions
UDI-DI code: 05407010540024
Reference / catalog number: PQ2K021P01

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View device family (Basic UDI)

Manufacturer information

Organization name: PRIME Medical Solutions
SRN: BE-MF-000018858
Manufacturer status: Active

Critical warnings

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

CW273
See IFU
CW030
See IFU
CW010
See IFU

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Market distribution

Primary placement in Belgium; available across 1 country total.

Country	On market since	Until
BelgiumPrimary placement	Jan 1, 2020	Still on market

Device identification

Trade name: not provided
UDI-DI code: 05407010540024
Basic UDI-DI: 540701054Q2K02TT
Reference / catalog number: PQ2K021P01
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: Q2K-02 pump mechanical (8L), ACB
Additional information URL: https://www.ifu.solutions/
Clinical sizes: No clinical sizes registered for this device.

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.

V080701ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES

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.