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Organization name
UDI-DI code
Reference / catalog number

PQ2K022P01 — Class I MDR by PRIME Medical Solutions

MD Atlas
PRIME Medical Solutions

EUDAMED last updated this device on Nov 6, 2023

PQ2K022P01

540701054Q2K02TT

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PRIME Medical Solutions
UDI-DI code: 05407010543155
Reference / catalog number: PQ2K022P01

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Manufacturer information

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

Critical warnings

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

CW273
See IFU
CW023
See IFU
CW030
See IFU
CW010
See IFU
CW139
See IFU
CW014
See IFU
CW259
See IFU

Market distribution

Primary placement in Belgium; available across 2 countries total.

Country	On market since	Until
BelgiumPrimary placement	Jun 1, 2023	Still on market
Norway	Jun 1, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 05407010543155
Basic UDI-DI: 540701054Q2K02TT
Reference / catalog number: PQ2K022P01
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), ABC
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

PQ30311P01540701054Q303Y2On the market PQ30321P01540701054Q303Y2On the market C_1034_S1 (100x200), BariCell540701054PMSCOVERUWOn the market C_1034_S1 (120x200), BariCell540701054PMSCOVERUWOn the market C_1034_S1 (140x200), BariCell540701054PMSCOVERUWOn 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.