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DemeCRYL G282037B6P

by DemeTECH Corp

Ref G282037B6P

DemeCRYL G282037B6P is a device classified as Class III in the EU and Class II in the US made by DemeTECH Corp, registered in EUDAMED on 4 Aug 2026 (Basic UDI-DI B-10652927668282), cleared under FDA 510(k) K043539 on 6 Apr 2005 and listed in FDA GUDID since 23 Jul 2019 (UDI-DI 10652927668282), active as of 24 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K043539

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10652927668282 Basic UDI-DI 10652927668282UDI-DIDate4 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10652927668282 UDI-DI Date23 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK043539 Date6 Apr 2005DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10652927668282 registered 4 Aug 2026 Active
  • FDA 510(k) K043539 decided 6 Apr 2005 Active
  • FDA GUDID UDI-DI 10652927668282 listed 23 Jul 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K043539
  2. Listed FDA GUDID 10652927668282
  3. Registered EUDAMED B-10652927668282

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
DemeCRYL
Generic name
Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Model / reference
G282037B6P
Description
Synthetic (polyglactin 910) , Absorbable Suture
Primary DI / UDI-DI
10652927668282
Basic UDI-DI
B-10652927668282
510(k) Number
FDA product code
GAM
EMDN code
H010101020201 Polyglycolic with lactic acid multifilament with needle for open surgery
GMDN term
Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Device class
Class III EUDAMED
Class II GUDID
Regulation number
878.4493
EU registration type
Legacy device (under a directive)
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

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: Polyester suture, bioabsorbable, multifilament, non-antimicrobial

Cleared under the same submission (K043539)

and 8 more cleared under K043539

Similar devices in this category

Other devices filed under POLYGLYCOLIC WITH LACTIC ACID MULTIFILAMENT WITH NEEDLE FOR OPEN SURGERY.

Other devices from DemeTECH Corp

See all devices from DemeTECH Corp →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)