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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

58878 — IVDR Class B IVDR by Tcoag ireland ltd

MD Atlas
Tcoag ireland ltd

EUDAMED last updated this device on Apr 9, 2026

58878

53915214QUARKPM

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Tcoag ireland ltd
UDI-DI code: 05391521421821
Reference / catalog number: 58878

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Manufacturer information

Organization name: Tcoag ireland ltd
SRN: IE-MF-000027371
Manufacturer status: Active

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW008
warning, biohazard
CW999
Warning laser beam
CW257
warning, risk of hand crushing

Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Jul 1, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 05391521421821
Basic UDI-DI: 53915214QUARKPM
Reference / catalog number: 58878
Issuing entity: GS1

Classification

Risk category: IVDR Class B
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The sthemA 601 analyzer is an automated quantitative hematology platform for in vitro diagnostic use by clinical laboratory personnel. It is used as an aid in the diagnosis of various conditions affecting the blood cells by performing a complete blood count (CBC) with the identification and enumeration of subpopulations of human cells in whole blood samples collected with a K2EDTA or K3EDTA anticoagulant.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0202010101AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.