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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

PP109 — IVDR Class B IVDR by SC MEDICAL PSIHO GRUP SRL

MD Atlas
SC MEDICAL PSIHO GRUP SRL

EUDAMED last updated this device on Nov 29, 2022

PP109

594476024ColSG125588881Z5

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: SC MEDICAL PSIHO GRUP SRL
UDI-DI code: 05944760240274
Reference / catalog number: PP109

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View device family (Basic UDI)

Manufacturer information

Organization name: SC MEDICAL PSIHO GRUP SRL
SRN: RO-MF-000030921
Manufacturer status: Active

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Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Romania; available across 1 country total.

Country	On market since	Until
RomaniaPrimary placement	Nov 30, 2022	Dec 31, 2029

Device identification

Trade name: not provided
UDI-DI code: 05944760240274
Basic UDI-DI: 594476024ColSG125588881Z5
Reference / catalog number: PP109
Issuing entity: GS1

Classification

Risk category: IVDR Class B
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 20000
Additional product description: Columbia Agar Base is a nutrient-rich formula containing 5% defibrinated blood, which provides more nutrients and the ability to exhibit hemolytic reactions
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
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05944760240274

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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.

W0104010405NON-CHROMOGENIC MEDIA (PLATES)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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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.