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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

Rolls for Cardiette — Class I MDR by EF Medica Srl

MD Atlas
EF Medica Srl

EUDAMED last updated this device on Jul 8, 2024

Rolls for Cardiette

803304054EFELEECGBR

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: EF Medica Srl
UDI-DI code: 08033040541044
Reference / catalog number: 11.130.01

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View device family (Basic UDI)

Manufacturer information

Organization name: EF Medica Srl
SRN: IT-MF-000009938
Manufacturer status: Active

Related devices

Compatible electrodes for defibrillation803304054EFELEECGBROn the market Compatible electrodes for defibrillation803304054EFELEECGBROn the market Compatible electrodes for defibrillation803304054EFELEECGBROn the market Clamp electrode803304054EFELEECGBROn the market Clamp electrode803304054EFELEECGBROn 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.

Critical warnings

No critical warnings reported for this device.

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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: Rolls for Cardiette
UDI-DI code: 08033040541044
Basic UDI-DI: 803304054EFELEECGBR
Reference / catalog number: 11.130.01
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: 10
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 130 MU50
25 MU36

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08033040541044

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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.

Z1302DIAGNOSTIC REGISTRATION PAPERS

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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