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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

SET OF CONTROL SAMPLES – SCS — IVDD — Annex II List A IVDD

MD Atlas
Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach

EUDAMED last updated this device on Mar 15, 2024

SET OF CONTROL SAMPLES – SCS

B-05904365620123

On the marketIVDD — Annex II List A

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach
UDI-DI code: 05904365620123
Reference / catalog number: 926

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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: SET OF CONTROL SAMPLES – SCS
UDI-DI code: 05904365620123
Basic UDI-DI: B-05904365620123
Reference / catalog number: 926
Issuing entity: GS1

Classification

Risk category: IVDD — Annex II List A
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The Set of Control Sample consists of two "patient sample" test tubes each containing 5 ml of red cell and plasma suspension (haematocrit 15% +/-2%): • Control Sample 1 926-K1 - Group B RhD+ DCcEe K+, • Control Sample 2 926-K2 - group A RhD- dccee K -, with anti-D antibodies.
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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Manufacturing date
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Software identification

UDI-DI DataMatrix

Encoded

(01)05904365620123

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0103030402CONTROL KITS (IMMUNOHAEMATOLOGY)

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.