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Swift Loop

by Coroneo Inc. 3 variants

Ref 1010643

Swift Loop (1010643) is a device classified as Class IIa in the EU and Class I in the US made by Coroneo Inc, registered in EUDAMED on 28 Jul 2023 (Basic UDI-DI B-1010643TY) and listed in FDA GUDID since 28 Jun 2023 (UDI-DI D-1010643TY), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-1010643TY Basic UDI-DI Date28 Jul 2023RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-1010643TY UDI-DI Date28 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-1010643TY registered 28 Jul 2023 Active
  • FDA GUDID UDI-DI D-1010643TY listed 28 Jun 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D-1010643TY
  2. Registered EUDAMED B-1010643TY

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Surgical vessel loop
Device name
Swift Loop 12", box of 20 (10 x 2 units)
Model / Ref / Catalog
1010643
Primary DI / UDI-DI
D-1010643TY, 10817121000461
Basic UDI-DI
B-1010643TY, B-10817121000461
FDA product code
GAE
EMDN code
H900203 Occlusion tapes, vascular structures
GMDN term
Surgical vessel loop
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4800
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Manufacturer details

EUDAMED SRN
CA-MF-000019141
Authorised representative
Obelis s.a. BE-AR-000000106

Similar devices in this category

Other devices filed under TAPES, MEDICAL/SURGICAL.

Other devices from Coroneo Inc

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)