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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

FP-197 — IVDD — General IVDD by OACP IE LTD

MD Atlas
OACP IE LTD

EUDAMED last updated this device on Dec 21, 2025

FP-197

B-5391540380FP-197TY8R

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: OACP IE LTD
UDI-DI code: D-5391540380FP-197TY8R
Reference / catalog number: FP-197

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Manufacturer information

Organization name: OACP IE LTD
SRN: IE-MF-000003506
Manufacturer status: Active

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FP-154B-5391540380FP-154TE66On the market FP-143B-5391540380FP-143T954On the market FP-206-2B-5391540380FP-206-2YXNSOn the market FP-186B-5391540380FP-186TT83On the market FP-085B-5391540380FP-085TL73On 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.

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: D-5391540380FP-197TY8R
Basic UDI-DI: B-5391540380FP-197TY8R
Reference / catalog number: FP-197
Issuing entity: EUDAMED

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC 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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