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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

Bicarbon Fitline Aortic and… — Class IIa MDR by Corcym S.r.l.

MD Atlas
Corcym S.r.l.

EUDAMED last updated this device on May 14, 2026

Bicarbon Fitline Aortic and Mitral Rotators Set

8022057ROTBICAXB

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Corcym S.r.l.
UDI-DI code: 08022057014610
Reference / catalog number: ICV0732

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View device family (Basic UDI)

Manufacturer information

Organization name: Corcym S.r.l.
SRN: IT-MF-000027865
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW011
Consult instructions for use

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Nov 6, 2025	Nov 2, 2030

Device identification

Trade name: Bicarbon Fitline Aortic and Mitral Rotators Set
UDI-DI code: 08022057014610
Basic UDI-DI: 8022057ROTBICAXB
Reference / catalog number: ICV0732
Issuing entity: GS1

Classification

Risk category: Class IIa
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.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08022057014610

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

P07038003MECHANICAL HEART VALVE IMPLANT ACCESSORIES

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

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Certificates

Certificate health across this manufacturer's portfolio.

G15 001664 0070Issued
Quality management systemNotified body: 0123Expiry: Nov 2, 2030
G12 001664 0050Issued
Quality management systemNotified body: 0123Expiry: Apr 3, 2028