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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

EntericBio Workstation — IVDR Class A IVDR by Serosep Limited

MD Atlas
Serosep Limited

EUDAMED last updated this device on Aug 5, 2022

EntericBio Workstation

0539151387INST2R

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Serosep Limited
UDI-DI code: 05391513879630
Reference / catalog number: 5070000450

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Manufacturer information

Organization name: Serosep Limited
SRN: IE-MF-000020322
Manufacturer status: Active

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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.

Critical warnings

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

CW273
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Ireland; available across 1 country total.

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

Device identification

Trade name: EntericBio Workstation
UDI-DI code: 05391513879630
Basic UDI-DI: 0539151387INST2R
Reference / catalog number: 5070000450
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: https://www.serosep.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W02060199ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Software identification