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Organization name
UDI-DI code
Reference / catalog number

FU1200 — Class IIa MDR by MEDKONSULT medical…

MD Atlas
MEDKONSULT medical technology s.r.o.

EUDAMED last updated this device on May 17, 2022

FU1200

859421157DANFLOWPS

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MEDKONSULT medical technology s.r.o.
UDI-DI code: 08594211570107
Reference / catalog number: FU1200

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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 2 countries total.

Country	On market since	Until
CzechiaPrimary placement	Jun 1, 2022	Still on market
Italy		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08594211570107
Basic UDI-DI: 859421157DANFLOWPS
Reference / catalog number: FU1200
Issuing entity: GS1

Classification

Risk category: Class IIa
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: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z121605UROFLOWMETERS

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

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