- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Apr 28, 2026
8011809GAR6CPNSNWPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →H43D1010FNS is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Santex S.p.A.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →08011809021785Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →8011809GAR6CPNSNWH43D1010FNSUDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →(01)08011809021785
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
European Medical Device Nomenclature — the EU product classification assigned to this device.
M0201020202COTTON GAUZES, FOLDED, WITH X-RAY DETECTABLE THREAD, NON-STERILEM0201020102COTTON GAUZES, FOLDED, WITHOUT X-RAY DETECTABLE THREAD, NON-STERILE2 warnings recorded — scroll inside the panel to see all entries.
CW009CW007Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary placement in Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Still on market |
IT-MF-000010188Certificate health across this manufacturer's portfolio.
MDR 00155-AIssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →MDR 00155-A8011809MutandinaQ7On the marketAbsorbeo Brief Extra size Large8011809MutandinaQ7On the marketAbsorbeo Brief Extra size Medium8011809MutandinaQ7On the marketAbsorbeo Brief Maxi size Extra-Large8011809MutandinaQ7On the marketAbsorbeo Brief Maxi size Large8011809MutandinaQ7On the market