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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

BEN0013 — Class I MDR by Sixtem Life Srl

MD Atlas
Sixtem Life Srl

EUDAMED last updated this device on Oct 2, 2024

BEN0013

803277984BENPEDTUTORIFT

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sixtem Life Srl
UDI-DI code: 08032779840183
Reference / catalog number: BEN0013

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View device family (Basic UDI)

Manufacturer information

Organization name: Sixtem Life Srl
SRN: IT-MF-000022977
Manufacturer status: Active

Critical warnings

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

CW135
EUDAMED did not publish a description for this code.

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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: 08032779840183
Basic UDI-DI: 803277984BENPEDTUTORIFT
Reference / catalog number: BEN0013
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: BENPED DITA A MARTELLO DESTRO GRANDE 1 PZ
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 1 PEZZO

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08032779840183

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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.

Y061203ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)

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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Related devices

BEN0019803277984BENPEDTUTORIFTOn the market BEN0022803277984BENPEDTUTORIFTOn the market BEN0001/A803277984BENPEDCEROTTIAJOn the market BEN0002803277984BENPEDCEROTTIAJOn the market CRY0002803277984CRYOKLEEN5JOn the market

Certificates

Certificate health across this manufacturer's portfolio.

55191Issued
Quality management systemNotified body: 0546Expiry: Dec 22, 2027