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Cor-Vasc

by Coroneo Inc.

Ref 1010771

Cor-Vasc (1010771) is a device classified as Class IIa in the EU and Class I in the US made by Coroneo Inc, registered in EUDAMED on 13 Jul 2023 (Basic UDI-DI B-1010771UA) and listed in FDA GUDID since 28 Jun 2023 (UDI-DI D-1010771UA), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-1010771UA Basic UDI-DI D-1010771UAUDI-DIDate13 Jul 2023RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-1010771UA UDI-DI Date28 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-1010771UA registered 13 Jul 2023 Active
  • FDA GUDID UDI-DI D-1010771UA listed 28 Jun 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D-1010771UA
  2. Registered EUDAMED B-1010771UA

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  • Withdrawn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

Trade name
Cor-Vasc EUDAMED
Stabilizer for articulated arm GUDID
Generic name
Surgical retractor/retraction system blade, reusable
Device name
Stabilizer assembly with pedestals - articulated arm
Model / Ref / Catalog
1010771
Primary DI / UDI-DI
D-1010771UA EUDAMED
00817121000181 GUDID
Basic UDI-DI
B-1010771UA
FDA product code
DWS
EMDN code
C03900299 Beating heart cardiosurgery devices - other
GMDN term
Surgical retractor/retraction system blade, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
870.4500
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-1010771UA
GUDID
00817121000181
Device classEUDAMED
Class IIa
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-1010771UA; FDA GUDID lists 00817121000181), so their flags are not compared. 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 BEATING HEART CARDIOSURGERY DEVICES - OTHER.

Other devices from Coroneo Inc

See all devices from Coroneo Inc →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (16, all answered No)