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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

sthemA 601 (Quark) and Autoloader — IVDD — General IVDD

MD Atlas
Tcoag ireland ltd

EUDAMED last updated this device on Jan 25, 2023

sthemA 601 (Quark) and Autoloader

B-05391521421821

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC 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

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.

Critical warnings

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

CW008
RISK OF BIOLOGICAL CONTAMINATION / RISK OF INJURY
CW011
Caution, risk of hand crushing
CW999
Laser radiation hazard

Market distribution

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: sthemA 601 (Quark) and Autoloader
UDI-DI code: 05391521421821
Basic UDI-DI: B-05391521421821
Reference / catalog number: 58878
Issuing entity: GS1

Classification

Risk category: IVDD — General
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 sthemA-601 is an automated, in-vitro, quantitative haematology analyser of whole blood specimens.
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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