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

FGC-581-21T — Class I MDR by Cardio Surgical Ltd.

MD Atlas
Cardio Surgical Ltd.

EUDAMED last updated this device on Mar 6, 2026

FGC-581-21T

539155175FGC-581-21T6G

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Cardio Surgical Ltd.
UDI-DI code: 05391551755859
Reference / catalog number: FGC-581-21T

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: Cardio Surgical Ltd.
SRN: IE-MF-000011150
Manufacturer status: Active

Related devices

CS3-1006-13 539155175CS3-1006-13V2On the market CS3-1005-23 539155175CS3-1005-23UWOn the market FSB-787-21 539155175FSB-787-213EOn the market MAH04 539155175MAH04A2On the market CS9-1048-03 539155175CS9-1048-0336On 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 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: 05391551755859
Basic UDI-DI: 539155175FGC-581-21T6G
Reference / catalog number: FGC-581-21T
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on 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)

L03130401TISSUE AND ORGAN GRASPING FORCEPS, REUSABLE

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification