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Dagrofil

by B. Braun Surgical, S.A. Spain EUDAMEDGUDID

Ref C0858188

Product code GATEMDN H010201020201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number40392390000005652L Basic UDI-DIDate29 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653709762 UDI-DIDate16 Aug 2015ListedStatusListed

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Generic Name
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
Model / Ref / Catalog
C0858188
Primary DI / UDI-DI
04038653709762
Basic UDI-DI
40392390000005652L
Unit of Use DI
04046963040970
FDA Product Code
GAT
EMDN Code
H010201020201 Polyester multifilament with needle for open surgery
GMDN Term
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.5000
Market of Registration
Germany
Commercial Distribution
Not in Commercial Distribution
Size
Length — 45.00 Centimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
ES-MF-000002083

Other devices from B. Braun Surgical, S.A.

See all devices from B. Braun Surgical, S.A. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Implantable NoEUDAMEDYesGUDID
  • CMR Substance
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
Other properties (17)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED d4e54149-f4a3-46ae-a5e7-5a96f56f235c 61 fields · synced 24 Oct 2026
  • FDA UDI 66f0b6e1-0727-49ae-a25e-2e8b04833c08 37 fields · synced 29 May 2026