Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

PBS – buffered salt solution pH… — 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 (5 liters)

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: 05904365620307
Reference / catalog number: 656

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

View device family (Basic UDI)

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.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

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 (5 liters)
UDI-DI code: 05904365620307
Basic UDI-DI: 5904365620PBSBL
Reference / catalog number: 656
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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05904365620307

Sign in to download the DataMatrix

Create a free account to download the UDI-DI DataMatrix for this device.

Email

Password

No account yet?

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

Sign in to generate the UDI-PI DataMatrix

Create a free account, then generate the compliant UDI-PI carrier for this device.

Email

Password

No account yet?

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

Become a partner of MD Atlas

Related devices

2-ME solution for the differrentiation of IgM and IgG antibodies5904365620MEH4On the market AB Group Serum5904365620KOLBLOn the market Anti-IgG reagentB-05904365620222On the market Coated Standardized Red Blood Cells ORhD+ with anti-D antibodiesB-05904365620109On the market Coated Standardized Red Blood Cells ORhD+ with anti-D antibodies READY TO USEB-05904365620116On the market

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.