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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

031114-HE — IVDR Class A IVDR by OACP IE LTD

MD Atlas
OACP IE LTD

EUDAMED last updated this device on May 6, 2022

031114-HE

539154038031114-HEAM

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: OACP IE LTD
UDI-DI code: 53915403800558
Reference / catalog number: 031114-HE

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Manufacturer information

Organization name: OACP IE LTD
SRN: IE-MF-000003506
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

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

CW011
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: not provided
UDI-DI code: 53915403800558
Basic UDI-DI: 539154038031114-HEAM
Reference / catalog number: 031114-HE
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: 100
Additional product description: used to dilute the ISH genetic probes during the ISH test protocols and to reduce the hybridization time up to 40 minutes (instead of the standard overnight).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01030703DNA IN SITU HYBRIDISATION REAGENTS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Software identification