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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

FIBRA OTTICA LASER W00UM T METRI… — Class IIa MDR

MD Atlas
GARDA LASER S.A.S. DI CUCINOTTA SALVATORE

EUDAMED last updated this device on Dec 9, 2025

FIBRA OTTICA LASER W00UM T METRI PF1WT00

805296141PFUK

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GARDA LASER S.A.S. DI CUCINOTTA SALVATORE
UDI-DI code: 08052961410055
Reference / catalog number: FIBRA OTTICA LASER W00UM T METRI PF1WT00

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View device family (Basic UDI)

Manufacturer information

Organization name: GARDA LASER S.A.S. DI CUCINOTTA SALVATORE
SRN: IT-MF-000024386
Manufacturer status: Active

Critical warnings

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

CW010
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	Jul 3, 2025	Jul 2, 2030

Device identification

Trade name: not provided
UDI-DI code: 08052961410055
Basic UDI-DI: 805296141PFUK
Reference / catalog number: FIBRA OTTICA LASER W00UM T METRI PF1WT00
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: Active non-implantable devices using non-ionizing radiation
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)08052961410055

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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.

Z12011085LASER SURGERY INSTRUMENTS - CONSUMABLES

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

KIT TIP LASER W00UM TL6W0805296141TLVBOn the market

Certificates

Certificate health across this manufacturer's portfolio.

IT343904Issued
Quality management systemNotified body: 1370Expiry: Jul 2, 2030
IT343904Issued
Quality management systemNotified body: 1370Expiry: Jul 2, 2030