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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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Coated Standardized Red Blood Cells… — 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 ORhD+ with anti-D antibodies READY TO USE

B-05904365620116

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

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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-05904365620116
Device name: Coated Standardized Red Blood Cells ORhD+ with anti-D antibodies READY TO USE
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

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basicUdiUlid01HS0H4XDDV8GV759W7D68W9M6

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 ORhD+ with anti-D antibodies READY TO USE05904365620116