Skip to content

Filapron PCL30523UZ

by Meril Endo Surgery Private Limited

Ref MEC/BRC/013

Filapron PCL30523UZ is a device classified as Class III in the EU and Class II in the US made by Meril Endo Surgery Private Limited, registered in EUDAMED on 13 May 2025 (Basic UDI-DI 89042552MES_PCL05VW) with CE/MDR certificate G70 105557 0008 valid until 19 Feb 2030, cleared under FDA 510(k) K172659 on 28 Sep 2017 and listed in FDA GUDID since 6 Nov 2018 (UDI-DI 18904255222776), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

19 Feb 2030

CE MDR certificate

FDA recalls

None found

in data synced 25 Oct 2026

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

510(k) K172659

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberG70 105557 0008 Date30 Jun 2026IssuedStatusActive expires 19 Feb 2030
United StatesGUDID listing GUDID Number18904255222776 UDI-DI Date6 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK172659 Date28 Sep 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 89042552MES_PCL05VW registered 13 May 2025 Active· +1 more in the status table
  • FDA 510(k) K172659 decided 28 Sep 2017 Active
  • FDA GUDID UDI-DI 18904255222776 listed 6 Nov 2018 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Timeline

5 dated events

  1. Cleared FDA 510(k) K172659
  2. Listed FDA GUDID 18904255222776
  3. Registered EUDAMED 89042552MES_PCL05VW
  4. Certificate issued EUDAMED G70 105557 0008
  5. Certificate expires EUDAMED G70 105557 0008

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Filapron™ Polyglecaprone 25 Suture EUDAMED
Filapron GUDID
Generic name
Poliglecaprone suture
Device name
FILAPRON™/ASPIRON™ Absorbable Poly (Glycolide-Co-Caprolactone) Surgical Suture
Model / Ref / Catalog
MEC/BRC/013 EUDAMED
PCL30523UZ GUDID
Primary DI / UDI-DI
18904255222776
Basic UDI-DI
89042552MES_PCL05VW
510(k) Number
FDA product code
GAM
EMDN code
H010101010301, H010101010302
GMDN term
Poliglecaprone suture
Device class
Class III EUDAMED
Class II GUDID
Regulation number
878.4493
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
MEC/BRC/013
GUDID
PCL30523UZ
Device classEUDAMED
Class III
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Poliglecaprone suture

Cleared under the same submission (K172659)

and 8 more cleared under K172659

Similar devices in this category

Other devices filed under POLIGLECAPRONE AND DERIVATIVES MONOFILAMENT WITH NEEDLE.

Other devices from Meril Endo Surgery Private Limited

See all devices from Meril Endo Surgery Private Limited →

Properties

  • Supplied sterile
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)