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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

CL-004 — IVDR Class A IVDR by OACP IE LTD

MD Atlas
OACP IE LTD

EUDAMED last updated this device on Nov 22, 2022

CL-004

069718082CL0045L

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: 0069718CL0123G
Reference / catalog number: CL-004

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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.

Market distribution

Primary placement in Italy; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 0069718CL0123G
Basic UDI-DI: 069718082CL0045L
Reference / catalog number: CL-004
Issuing entity: IFA

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)

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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Manufacturing date
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Software identification