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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

FR5D4040X4INA — Class IIa MDR by Santex S.p.A.

MD Atlas
Santex S.p.A.

EUDAMED last updated this device on Apr 28, 2026

FR5D4040X4INA

8011809GAR6LAPNS2L

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Santex S.p.A.
UDI-DI code: 08011809021457
Reference / catalog number: FR5D4040X4INA

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View device family (Basic UDI)

Manufacturer information

Organization name: Santex S.p.A.
SRN: IT-MF-000010188
Manufacturer status: Active

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Critical warnings

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

CW009
Do not re-use
CW007
Do not use if package is damaged

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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: 08011809021457
Basic UDI-DI: 8011809GAR6LAPNS2L
Reference / catalog number: FR5D4040X4INA
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: 50
Additional product description: —
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)08011809021457

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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.

M0201030202LAPAROTOMY COTTON GAUZES, WITH X-RAY DETECTABLE THREAD, NON-STERILE
M0201030102LAPAROTOMY COTTON GAUZES, WITHOUT X-RAY DETECTABLE THREAD, NON-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.

MDR 00155-AIssued
Quality management systemNotified body: 0476Expiry: Jun 17, 2030