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Organization name
UDI-DI code
Reference / catalog number

PC8916_007 — Class IIa 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

PC8916_007

85956104SFL6G

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Dr. Müller Pharma s.r.o.
UDI-DI code: 08595610406127
Reference / catalog number: PC8916_007

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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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Market distribution

Primary placement in Romania; available across 1 country total.

Country	On market since	Until
RomaniaPrimary placement	Jul 25, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08595610406127
Basic UDI-DI: 85956104SFL6G
Reference / catalog number: PC8916_007
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)

V9017ORAL ADMINISTRATION PREPARATIONS NOT INCLUDED IN OTHER CLASSES

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-031Issued
Quality management systemNotified body: 2265Expiry: Oct 20, 2028