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Cor-Valv

by Coroneo Inc. 3 variants

Ref 1011181

Cor-Valv (1011181) 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-1011181TN) and listed in FDA GUDID since 30 Jun 2023 (UDI-DI D-1011181TN), 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-1011181TN Basic UDI-DI D-1011181TNUDI-DIDate28 Jul 2023RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-1011181TN UDI-DI Date30 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-1011181TN registered 28 Jul 2023 Active
  • FDA GUDID UDI-DI D-1011181TN listed 30 Jun 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D-1011181TN
  2. Registered EUDAMED B-1011181TN

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  • Withdrawn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-Valv EUDAMED
COR-VALV Aortic retractor cables with fitting GUDID
Generic name
Surgical retractor/retraction system blade, reusable
Device name
Aortic retractor cable with fitting
Model / Ref / Catalog
1011181
Primary DI / UDI-DI
D-1011181TN EUDAMED
10817121000201 GUDID
Basic UDI-DI
B-1011181TN
FDA product code
GAD
EMDN code
K01020106 Minimally invasive surgery spreaders and retractors, single-use
GMDN term
Surgical retractor/retraction system blade, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4800
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-1011181TN
GUDID
10817121000201
Device classEUDAMED
Class IIa
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-1011181TN; FDA GUDID lists 10817121000201), 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 MINIMALLY INVASIVE SURGERY SPREADERS AND RETRACTORS, SINGLE-USE.

Other devices from Coroneo Inc

See all devices from Coroneo Inc →

Properties

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