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Spreader arm - rack side

by Coroneo Inc.

Ref 1011378

Spreader arm - rack side (1011378) is a device classified as Class IIa in the EU and Class I in the US made by Coroneo Inc, registered in EUDAMED on 12 Jul 2023 (Basic UDI-DI B-00817121000358) and listed in FDA GUDID since 29 Sep 2022 (UDI-DI 00817121000358), 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-00817121000358 Basic UDI-DI 00817121000358UDI-DIDate12 Jul 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00817121000358 UDI-DI Date29 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00817121000358 registered 12 Jul 2023 Active
  • FDA GUDID UDI-DI 00817121000358 listed 29 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00817121000358
  2. Registered EUDAMED B-00817121000358

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  • Withdrawn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
Spreader arm - rack side EUDAMED
Spreader Arm - Rack Side (large) GUDID
Generic name
Rib spreader, reusable
Model / Ref / Catalog
1011378
Primary DI / UDI-DI
00817121000358 EUDAMED
10817121000331 GUDID
Basic UDI-DI
B-00817121000358
FDA product code
GAD
EMDN code
L08060299 Thoracic surgery spreaders, reusable - other
GMDN term
Rib spreader, 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
France
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
00817121000358
GUDID
10817121000331
Device classEUDAMED
Class IIa
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00817121000358; FDA GUDID lists 10817121000331), 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 THORACIC SURGERY INSTRUMENTS, REUSABLE.

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)