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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

00975 — IVDR Class A IVDR by Diagnostica Stago

MD Atlas
Diagnostica Stago

EUDAMED last updated this device on Nov 17, 2022

00975

3607450AUXI0006RW

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Diagnostica Stago
UDI-DI code: 13607450009757
Reference / catalog number: 00975

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Manufacturer information

Organization name: Diagnostica Stago
SRN: FR-MF-000017089
Manufacturer status: Active

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86923B-13607450869238On the market 86922B-13607450869221On the market 00615B-03607450006155On the market 00624B-03607450006247On the market 00947B-03607450009477On 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.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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: not provided
UDI-DI code: 13607450009757
Basic UDI-DI: 3607450AUXI0006RW
Reference / catalog number: 00975
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: 24
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)

W0103020999AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
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Software identification