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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

Thrombo-Aggregometer — IVDR Class A IVDR by SD Innovation

MD Atlas
SD Innovation

EUDAMED last updated this device on Jan 19, 2024

Thrombo-Aggregometer

3770025379TH-V3ZC

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: SD Innovation
UDI-DI code: 03770025379135
Reference / catalog number: TA-8V

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Manufacturer information

Organization name: SD Innovation
SRN: FR-MF-000003775
Manufacturer status: Active

Critical warnings

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

CW273
This instrument is intended for indoor use only. Failure to operate in a protected environment in accordance with instructions may present a shock hazard.
CW023
Failure to operate in a protected environment in accordance with instructions may present hazards from magnetic fields.
CW010
Read instructions for use carefully before using the instrument.
CW168
Normal precautions, which apply to the handling of blood, should be observed in handling the samples.

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: Thrombo-Aggregometer
UDI-DI code: 03770025379135
Basic UDI-DI: 3770025379TH-V3ZC
Reference / catalog number: TA-8V
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0202029099VARIOUS HEMOSTASIS INSTRUMENTS - OTHER

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

Related devices

Glass tubes3770025379TH-CV-1000DYOn the market Glass tubes + Stir bars3770025379TH-CV+A-1000JYOn the market Stir bars3770025379TH-A-1000GNOn the market Thrombo-Aggregometer3770025379TH-V2ZAOn the market Thrombo-Aggregometer3770025379TH-V2ZAOn the market

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.