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EUDAMED last updated this device on Jul 29, 2026
84351660GA01EDACOMPRESA GASA DE ALGODÓN 13 HILOS 20X20 P/10X10 4C. 5UN/SOBRE ESTÉRIL is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by GASPUNT, S.A.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08435166015766SO132002(01)08435166015766
European Medical Device Nomenclature — the EU product classification assigned to this device.
M0201050101COTTON GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, STERILE2 warnings recorded — scroll inside the panel to see all entries.
ES-MF-000004842The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Spain; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | — | Still on market |
Sterile
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 DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic 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 →UDI 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 →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →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 →Certificate health across this manufacturer's portfolio.
2025 PR 0063IssuedNotified 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 →84351660GA01EDAOn the marketCOMPRESA GASA DE ALGODÓN 13 HILOS 20X30 P/10X8 8C. 5UN/SOBRE ESTÉRIL84351660GA02KFOn the marketCOMPRESA TNT 30 g/m2 20X20 P/10X10 5 UN/SOBRE EST84351660TNT01ENTOn the marketVENDA CREPE GASPUNT 4mX7cm F.P84351660VND01NYOn the marketNo certificate specifically references this device's Basic UDI-DI.