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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

PEN0001 — Class IIa MDR by Sixtem Life Srl

MD Atlas
Sixtem Life Srl

EUDAMED last updated this device on Jul 8, 2024

PEN0001

803277984VERRUGELPL

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sixtem Life Srl
UDI-DI code: 08032779840473
Reference / catalog number: PEN0001

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View device family (Basic UDI)

Manufacturer information

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

Related devices

BEN0013803277984BENPEDTUTORIFTOn the market BEN0019803277984BENPEDTUTORIFTOn the market BEN0022803277984BENPEDTUTORIFTOn the market BEN0001/A803277984BENPEDCEROTTIAJOn the market BEN0002803277984BENPEDCEROTTIAJOn the market

Certificates

Certificate health across this manufacturer's portfolio.

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

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
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.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08032779840473
Basic UDI-DI: 803277984VERRUGELPL
Reference / catalog number: PEN0001
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: Dispositivo medico per il trattamento di verruche
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 2 MU03

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08032779840473

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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.

M0412DRESSINGS FOR THE TREATMENT OF WARTS, CORNS AND CALLUSES

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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