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Organization name
UDI-DI code
Reference / catalog number

Dual Action Pump (Foot Variant) — Class I MDR

MD Atlas
Calyx Medical Sp. z o.o.

EUDAMED last updated this device on Mar 26, 2025

Dual Action Pump (Foot Variant)

59061689422URO057LE

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Calyx Medical Sp. z o.o.
UDI-DI code: 05906168942211
Reference / catalog number: URO 057

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View device family (Basic UDI)

Manufacturer information

Organization name: Calyx Medical Sp. z o.o.
SRN: PL-MF-000038787
Manufacturer status: Active

Related devices

Agitator59061689422URO059LJOn the market Dual Action Pump - Hand Variant59061689422URO058LGOn the market Sealing Connector (S-Piece)59061689422SUR021LMOn the market Sealing Connector (T-Piece)59061689422SUR019M2On the market Sealing Connector (Y-Piece)59061689422SUR020LKOn 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 Poland; available across 1 country total.

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

Device identification

Trade name: Dual Action Pump (Foot Variant)
UDI-DI code: 05906168942211
Basic UDI-DI: 59061689422URO057LE
Reference / catalog number: URO 057
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 Dual Action Pump (DAP) is a user-controlled manual pump that delivers a bolus of irrigation fluid to the upper urinary tract, while simultaneously draining the same volume. It is an evolution of the conventional irrigation devices available, as it has a suctioning capability in addition to the standard pumping function.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
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Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05906168942211

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z12019007IRRIGATORS

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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