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Organization name
UDI-DI code
Reference / catalog number

PS10-02U05 — Class I MDR by MEDKONSULT medical…

MD Atlas
MEDKONSULT medical technology s.r.o.

EUDAMED last updated this device on Nov 4, 2024

PS10-02U05

859421157ATMOSK7

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MEDKONSULT medical technology s.r.o.
UDI-DI code: 08594211570527
Reference / catalog number: PS10-02U05

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Manufacturer information

Organization name: MEDKONSULT medical technology s.r.o.
SRN: CZ-MF-000016193
Manufacturer status: Active

Market distribution

Primary placement in Czechia; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08594211570527
Basic UDI-DI: 859421157ATMOSK7
Reference / catalog number: PS10-02U05
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: urethral 0.5m for Harmony
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

U0580URODYNAMICS DEVICES - ACCESSORIES

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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MU1002859421157DANFLOWPSOn the market MU1102859421157DANFLOWPSOn the market MU1001859421157DANFLOWPSOn the market MU1101859421157DANFLOWPSOn the market FU1201859421157DANFLOWPSOn the market

Certificates

Certificate health across this manufacturer's portfolio.

2022-MDR/QS-001/ASupplemented
Quality management systemNotified body: 2265Expiry: Mar 21, 2027