Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

FR5D4545X4IXABL — Class IIa MDR by Santex S.p.A.

MD Atlas
Santex S.p.A.

EUDAMED last updated this device on Apr 28, 2026

FR5D4545X4IXABL

8011809GAR6LAPNS2L

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Santex S.p.A.
UDI-DI code: 08011809021464
Reference / catalog number: FR5D4545X4IXABL

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

View device family (Basic UDI)

Manufacturer information

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

Related devices

W32RE21C-248011809Rettangolari8KOn the market H23D1010SNSS8011809GAR6CPNSNWOn the market H33D1010SNS8011809GAR6CPNSNWOn the market H23D1020SNS8011809GAR6CPNSNWOn the market H43D1010SNSS8011809GAR6CPNSNWOn the market

Certificates

Certificate health across this manufacturer's portfolio.

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

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

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

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: 08011809021464
Basic UDI-DI: 8011809GAR6LAPNS2L
Reference / catalog number: FR5D4545X4IXABL
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)08011809021464

Sign in to download the DataMatrix

Create a free account to download the UDI-DI DataMatrix for this device.

Email

Password

No account yet?

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

Sign in to generate the UDI-PI DataMatrix

Create a free account, then generate the compliant UDI-PI carrier for this device.

Email

Password

No account yet?

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

Become a partner of MD Atlas