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Organization name
UDI-DI code
Reference / catalog number

PC0101_004 — Class I MDR by Dr. Müller Pharma s.r.o.

MD Atlas
Dr. Müller Pharma s.r.o.

EUDAMED last updated this device on Sep 3, 2024

PC0101_004

85956104USG7P

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Dr. Müller Pharma s.r.o.
UDI-DI code: 08595610405465
Reference / catalog number: PC0101_004

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Manufacturer information

Organization name: Dr. Müller Pharma s.r.o.
SRN: CZ-MF-000000005
Manufacturer status: Active

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Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW999
Kontraindikace: Známá přecitlivělost na některou ze složek přípravku. Upozornění: Nepoužívejte, pokud je obal porušen. Nepoužívejte po uplynutí data spotřeby uvedeném na obalu.

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: 08595610405465
Basic UDI-DI: 85956104USG7P
Reference / catalog number: PC0101_004
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11040185ULTRASOUND SCANNERS - CONSUMABLES

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

Certificates

Certificate health across this manufacturer's portfolio.

2023-MDR/QS-035/BSupplemented
Quality management systemNotified body: 2265Expiry: Oct 20, 2028
2023-MDR/QS-034/CSupplemented
Quality management systemNotified body: 2265Expiry: Oct 20, 2028
2023-MDR/QS-033/BSupplemented
Quality management systemNotified body: 2265Expiry: Oct 20, 2028
2023-MDR/QS-031refdata.certificate-status.reissued
Quality management systemNotified body: 2265Expiry: Oct 20, 2028
2023-MDR/QS-032Issued
Quality management systemNotified body: 2265Expiry: Oct 20, 2028

2023-MDR/QS-031

Issued

Quality management systemNotified body: 2265Expiry: Oct 20, 2028