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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

Felix-18 — Class I MDR by BIEMME GROUP SRL

MD Atlas
BIEMME GROUP SRL

EUDAMED last updated this device on Mar 6, 2023

Felix-18

805050779001AD

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BIEMME GROUP SRL
UDI-DI code: 08050507790029
Reference / catalog number: Felix-18

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View device family (Basic UDI)

Manufacturer information

Organization name: BIEMME GROUP SRL
SRN: IT-MF-000031381
Manufacturer status: Active

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LEONCINO M2805050779004AKOn the market LEO M2805050779004AKOn the market LEO M1805050779004AKOn the market Wally S3805050779003AHOn the market Felix-22805050779001ADOn 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: not provided
UDI-DI code: 08050507790029
Basic UDI-DI: 805050779001AD
Reference / catalog number: Felix-18
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: Ultralight Manual Wheelchair with carbon fiber main wheels. The lightest in the world: total weight only 3.2 kg
Additional information URL: https://www.biemmegroupsrl.it/
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)08050507790029

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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.

Y122106REAR SELF-PROPELLED WHEELCHAIRS

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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