Pricing Sign in

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.

Coated Standardized Red Blood Cells to… — 1 UDI-DI variant, IVDD

MD Atlas
Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach

Data from EUDAMED, last updated May 30, 2026

Coated Standardized Red Blood Cells to direct antiglobulin test control

B-05904365620093

1 UDI-DI variant

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]IVDD — Annex II List B

Legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk class: IVDD — Annex II List B
Manufacturer: Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach

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?

Device characteristics

ReagentProfessional testingHuman tissues / cells

Legacy certificates

Certificate number: 1434-IVDD-161/2022
Type: refdata.legacy.ivdd-certificate-type.iv-excluding-4-6
Notified body: POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. (1434)
Validity: May 27, 2025

Identity & classification

Basic UDI-DI: B-05904365620093
Device name: Coated Standardized Red Blood Cells to direct antiglobulin test control
Issuing agency: EUDAMED
Legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk class: IVDD — Annex II List B
Version date: Mar 15, 2024

Manufacturer & authorised representative

Manufacturer

Name: Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach
SRN: PL-MF-000037642
Country: Poland
Email: dpos@rckik-katowice.pl
Phone: +48 322087408

Variants by status

UDI-DI variants

1 UDI-DI variant

Sign in to export

Exports are reserved for signed-in users. Sign in or create an account to continue.

Email

Password

No account yet?

Export results

Applied filters

basicUdiUlid01HS0HKMPS2CGPFVPSHV87E3VY

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

Coated Standardized Red Blood Cells to direct antiglobulin test control05904365620093