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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

FCB-808-21T — Class I MDR by Cardio Surgical Ltd.

MD Atlas
Cardio Surgical Ltd.

EUDAMED last updated this device on Mar 3, 2026

FCB-808-21T

539155175FCB-808-21T2V

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Cardio Surgical Ltd.
UDI-DI code: 05391551755484
Reference / catalog number: FCB-808-21T

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Manufacturer information

Organization name: Cardio Surgical Ltd.
SRN: IE-MF-000011150
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 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: 05391551755484
Basic UDI-DI: 539155175FCB-808-21T2V
Reference / catalog number: FCB-808-21T
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: Micro-Forceps, STR DeBakey, jaws 1,2mm, HVY TOLEDO, 21cm CER
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