EUDAMED update: Feb 2, 2024

Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach

PL-MF-000037642

Active32 devices

Address: Raciborska, 15 40-074 Katowice
Role: Manufacturer
Date of registration: Sep 15, 2023
Country: Poland

Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach is a medical device manufacturer registered in EUDAMED. The company has 32 devices on the EU market in Poland. Headquartered in Katowice, Poland. Explore the regulatory profile, devices and certificates on MD Atlas.

About RCKiK w Katowicach

: PL-MF-000037642
Role: Manufacturer
Country: Poland
Organization name: Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach
EU VAT number: 6342336539
EORI: PL634233653900000
Trade register: 0000054747
Date of registration: Sep 15, 2023

Contact details for RCKiK w Katowicach

Phone: +48 322087408
Email: dpos@rckik-katowice.pl
Website: www.rckik-katowice.pl
Address: 15, RACIBORSKA 40-074 KATOWICE POLAND

Competent authority

Name: Urząd Rejestracji Produktów Leczniczych

Phone: +48 22 492 11 71
Email: wm@urpl.gov.pl

Officers and regulatory representatives of RCKiK w Katowicach

ROTHKEGEL- KAPICA Katarzyna
verification of compliance of the products with the quality management system, where the products are manufactured, before the release of the product, - the drawing up and updating of the technical documentation and the EU declaration of conformity, - compliance with post-market surveillance obligations - compliance with reporting obligations
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Product	Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
2-ME solution for the differrentiation of IgM and IgG antibodies	2-ME solution for the differrentiation of IgM and IgG antibodies	`918`	`05904365620321`	1	On the market
AB Group Serum	AB Group Serum	`663`	`05904365620239`	1	On the market
Anti-IgG reagent	Anti-IgG reagent	`899`	`05904365620222`	1	On the market
Coated Standardized Red Blood Cells ORhD+ with anti-D antibodies	Coated Standardized Red Blood Cells ORhD+ with anti-D antibodies	`515`	`05904365620109`	1	On the market
Coated Standardized Red Blood Cells ORhD+ with anti-D antibodies READY TO USE	Coated Standardized Red Blood Cells ORhD+ with anti-D antibodies READY TO USE	`915`	`05904365620116`	1	On the market
Coated Standardized Red Blood Cells to direct antiglobulin test control	Coated Standardized Red Blood Cells to direct antiglobulin test control	`514`	`05904365620093`	1	On the market
Dolichotest	Dolichotest	`133`	`05904365620246`	1	On the market
LISS - L Low ionic strenght salt solution	LISS - L Low ionic strenght salt solution	`108`	`05904365620260`	1	On the market
LISS-M (low ionic strength solution medium) is a salt solution with low ionic strength, standardised pH and osmolality values. LISS-M reagent is used for washing and preparing red cell suspensions for in vitro immunohaematology tests.	LISS-M (low ionic strength solution medium) is a salt solution with low ionic strength, standardised pH and osmolality values. LISS-M reagent is used for washing and preparing red cell suspensions for in vitro immunohaematology tests.	`911`	`05904365620277`	1	On the market
Papain ST	Papain ST	`107`	`05904365620147`	1	On the market
PBS – buffered salt solution pH 6,9 (5 liters)	PBS – buffered salt solution pH 6,9 (5 liters)	`656`	`05904365620307`	1	On the market
PBS buffered salt solution pH 6,9 (2liters)	PBS buffered salt solution pH 6,9 (2liters)	`655`	`05904365620291`	1	On the market
PBS zbuforowany fizjologiczny roztwór soli do badań serologicznych pH 6,9	PBS zbuforowany fizjologiczny roztwór soli do badań serologicznych pH 6,9	`111`	`05904365620284`	1	On the market
PEG - Polyethylene glycol solution for indirect antiglobulin test	PEG - Polyethylene glycol solution for indirect antiglobulin test	`105`	`05904365620253`	1	On the market
Polyvalent anti-human globulin serum (10x10ml)	Polyvalent anti-human globulin serum (10x10ml)	`912`	`05904365620215`	1	On the market
Polyvalent anti-human globulin serum (10x5ml)	Polyvalent anti-human globulin serum (10x5ml)	`103/10`	`05904365620192`	1	On the market
Polyvalent anti-human globulin serum (1x5ml)	Polyvalent anti-human globulin serum (1x5ml)	`103/1`	`05904365620208`	1	On the market
Preserved Standard Red Blood Cells. Set for the ABO system definition	Preserved Standard Red Blood Cells. Set for the ABO system definition	`508`	`05904365620017`	1	On the market
Preserved Standard Red Blood Cells. Set for the ABO system definition I	Preserved Standard Red Blood Cells. Set for the ABO system definition I	`576`	`05904365620024`	1	On the market
Preserved Standard Red Blood Cells. Set for the antibodies detection	Preserved Standard Red Blood Cells. Set for the antibodies detection	`509`	`05904365620031`	1	On the market
Preserved Standard Red Blood Cells. Set for the antibody identification	Preserved Standard Red Blood Cells. Set for the antibody identification	`510`	`05904365620048`	1	On the market
Preserved Standard Red Blood Cells. Set for the antibody identification PLUS	Preserved Standard Red Blood Cells. Set for the antibody identification PLUS	`913`	`05904365620055`	1	On the market
Reagents for elution The acid glycine, 10% EDTA, 1M TRIS	Reagents for elution The acid glycine, 10% EDTA, 1M TRIS	`919`	`05904365620314`	1	On the market
SET OF CONTROL SAMPLES – SCS	SET OF CONTROL SAMPLES – SCS	`926`	`05904365620123`	1	On the market
SET OF CONTROL SAMPLES I – SCS I	SET OF CONTROL SAMPLES I – SCS I	`931`	`05904365620130`	1	On the market

Product	Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
2-ME solution for the differrentiation of IgM and IgG antibodies	2-ME solution for the differrentiation of IgM and IgG antibodies	`918`	`05904365620321`	1	On the market
AB Group Serum	AB Group Serum	`663`	`05904365620239`	1	On the market
Anti-IgG reagent	Anti-IgG reagent	`899`	`05904365620222`	1	On the market
Coated Standardized Red Blood Cells ORhD+ with anti-D antibodies	Coated Standardized Red Blood Cells ORhD+ with anti-D antibodies	`515`	`05904365620109`	1	On the market
Coated Standardized Red Blood Cells ORhD+ with anti-D antibodies READY TO USE	Coated Standardized Red Blood Cells ORhD+ with anti-D antibodies READY TO USE	`915`	`05904365620116`	1	On the market
Coated Standardized Red Blood Cells to direct antiglobulin test control	Coated Standardized Red Blood Cells to direct antiglobulin test control	`514`	`05904365620093`	1	On the market
Dolichotest	Dolichotest	`133`	`05904365620246`	1	On the market
LISS - L Low ionic strenght salt solution	LISS - L Low ionic strenght salt solution	`108`	`05904365620260`	1	On the market
LISS-M (low ionic strength solution medium) is a salt solution with low ionic strength, standardised pH and osmolality values. LISS-M reagent is used for washing and preparing red cell suspensions for in vitro immunohaematology tests.	LISS-M (low ionic strength solution medium) is a salt solution with low ionic strength, standardised pH and osmolality values. LISS-M reagent is used for washing and preparing red cell suspensions for in vitro immunohaematology tests.	`911`	`05904365620277`	1	On the market
Papain ST	Papain ST	`107`	`05904365620147`	1	On the market
PBS – buffered salt solution pH 6,9 (5 liters)	PBS – buffered salt solution pH 6,9 (5 liters)	`656`	`05904365620307`	1	On the market
PBS buffered salt solution pH 6,9 (2liters)	PBS buffered salt solution pH 6,9 (2liters)	`655`	`05904365620291`	1	On the market
PBS zbuforowany fizjologiczny roztwór soli do badań serologicznych pH 6,9	PBS zbuforowany fizjologiczny roztwór soli do badań serologicznych pH 6,9	`111`	`05904365620284`	1	On the market
PEG - Polyethylene glycol solution for indirect antiglobulin test	PEG - Polyethylene glycol solution for indirect antiglobulin test	`105`	`05904365620253`	1	On the market
Polyvalent anti-human globulin serum (10x10ml)	Polyvalent anti-human globulin serum (10x10ml)	`912`	`05904365620215`	1	On the market
Polyvalent anti-human globulin serum (10x5ml)	Polyvalent anti-human globulin serum (10x5ml)	`103/10`	`05904365620192`	1	On the market
Polyvalent anti-human globulin serum (1x5ml)	Polyvalent anti-human globulin serum (1x5ml)	`103/1`	`05904365620208`	1	On the market
Preserved Standard Red Blood Cells. Set for the ABO system definition	Preserved Standard Red Blood Cells. Set for the ABO system definition	`508`	`05904365620017`	1	On the market
Preserved Standard Red Blood Cells. Set for the ABO system definition I	Preserved Standard Red Blood Cells. Set for the ABO system definition I	`576`	`05904365620024`	1	On the market
Preserved Standard Red Blood Cells. Set for the antibodies detection	Preserved Standard Red Blood Cells. Set for the antibodies detection	`509`	`05904365620031`	1	On the market
Preserved Standard Red Blood Cells. Set for the antibody identification	Preserved Standard Red Blood Cells. Set for the antibody identification	`510`	`05904365620048`	1	On the market
Preserved Standard Red Blood Cells. Set for the antibody identification PLUS	Preserved Standard Red Blood Cells. Set for the antibody identification PLUS	`913`	`05904365620055`	1	On the market
Reagents for elution The acid glycine, 10% EDTA, 1M TRIS	Reagents for elution The acid glycine, 10% EDTA, 1M TRIS	`919`	`05904365620314`	1	On the market
SET OF CONTROL SAMPLES – SCS	SET OF CONTROL SAMPLES – SCS	`926`	`05904365620123`	1	On the market
SET OF CONTROL SAMPLES I – SCS I	SET OF CONTROL SAMPLES I – SCS I	`931`	`05904365620130`	1	On the market

Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach

About RCKiK w Katowicach

Contact details for RCKiK w Katowicach

Competent authority

Officers and regulatory representatives of RCKiK w Katowicach

Related searches

About RCKiK w Katowicach

Contact details for RCKiK w Katowicach

Competent authority

Officers and regulatory representatives of RCKiK w Katowicach

Approved members

Statistics for RCKiK w Katowicach

Certificate health for RCKiK w Katowicach

Related documents

Devices by risk class

Device catalog for RCKiK w Katowicach

Device families (Basic UDI-DI) of RCKiK w Katowicach

Market presence of RCKiK w Katowicach

Related searches

Market presence of RCKiK w Katowicach

Devices by risk class

Approved members

Certificate health for RCKiK w Katowicach

Statistics for RCKiK w Katowicach

Device families (Basic UDI-DI) of RCKiK w Katowicach

Related documents

Device catalog for RCKiK w Katowicach