Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

FP-315-2 — IVDD — General IVDD by OACP IE LTD

MD Atlas
OACP IE LTD

EUDAMED last updated this device on Jan 11, 2026

FP-315-2

B-539154038FP-315-23DGG

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-539154038FP-315-23DGG
Reference / catalog number: FP-315-2

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

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-539154038FP-315-23DGG
Basic UDI-DI: B-539154038FP-315-23DGG
Reference / catalog number: FP-315-2
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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification