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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

58083514000000 — Class I MDR by Pikdare S.p.A.

MD Atlas
Pikdare S.p.A.

EUDAMED last updated this device on Apr 15, 2026

58083514000000

805809083514000LW

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Pikdare S.p.A.
UDI-DI code: 08058090048268
Reference / catalog number: 58083514000000

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View device family (Basic UDI)

Manufacturer information

Organization name: Pikdare S.p.A.
SRN: IT-MF-000010069
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	Aug 1, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08058090048268
Basic UDI-DI: 805809083514000LW
Reference / catalog number: 58083514000000
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: 4
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 10x10cm

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08058090048268

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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.

M0201010101COTTON GAUZE, CUT, WITHOUT X-RAY DETECTABLE THREAD, STERILE

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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Certificates

Certificate health across this manufacturer's portfolio.

ITH 1984728 1Issued
Quality management systemNotified body: 1936Expiry: May 2, 2027
ITH 1984728 1Supplemented
Quality management systemNotified body: 1936Expiry: May 2, 2027