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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

PBS buffered salt solution pH 6,9… — IVDR Class A IVDR

MD Atlas
Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach

EUDAMED last updated this device on Feb 2, 2024

PBS buffered salt solution pH 6,9 (2liters)

5904365620PBSBL

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach
UDI-DI code: 05904365620291
Reference / catalog number: 655

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Manufacturer information

Organization name: Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach
SRN: PL-MF-000037642
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Poland; available across 1 country total.

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

Device identification

Trade name: PBS buffered salt solution pH 6,9 (2liters)
UDI-DI code: 05904365620291
Basic UDI-DI: 5904365620PBSBL
Reference / catalog number: 655
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: PBS – buffered saline solution pH 6,9 reagent for in vitro serology diagnostic used for red blood cells washing and preparing suspensions of these cells, among others for: • determination of antigens of Rh and ABO group system (including when monoclonal reagents are used) • performance of direct and indirect antiglobulin tests • detection of natural irregular antibodies • performance of cross-matching tests between recipient and donor
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

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Software identification

UDI-DI DataMatrix

Encoded

(01)05904365620291

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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.

W0103030306ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)

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.