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EUDAMED last updated this device on Jun 2, 2025
89042552MES_PCL05VWASPIRON™ Polyglecaprone 25 Suture is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class III. Manufactured by Meril Endo Surgery Pvt. Ltd.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
18904255218809MEC/BRC/013(01)18904255218809
European Medical Device Nomenclature — the EU product classification assigned to this device.
H010101010302POLIGLECAPRONE AND DERIVATIVES MONOFILAMENT WITHOUT NEEDLEH010101010301POLIGLECAPRONE AND DERIVATIVES MONOFILAMENT WITH NEEDLE1 warning recorded — scroll inside the panel to see all entries.
"Surgeons should consider the in vivo performance (under ‘PERFORMANCE’ section) and should be familiar with surgical procedures and techniques involving absorbable sutures before employing Filapron™ suture for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used. In surgery of the urinary or biliary tracts, care should be taken to avoid prolonged contact of Filapron™ suture with salt solutions, to prevent calculus formation. This suture may be inappropriate in patients suffering from conditions which may delay wound healing e.g. patients that are elder, malnourished or debilitated. As this is an absorbable suture, the use of supplemental non-absorbable sutures should be considered by the surgeons in the closure of the abdomen, chest, joints or other sites subject to expansion or requiring additional support. "
IN-MF-000010999G70 105557 0008The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Mar 18, 2016 | 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.
1000316802RestrictedG70 105557 0008IssuedG15 105557 0007Issued1000214950IssuedNotified 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 →Notified 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 →Notified 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 →Notified 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 →