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DeRoyal 71-0031

by Pergo Medikal Ve Ilac Sanayi Anonim Sirketi

Part of a family of 138 devices: see the family page

Ref 71-0031

DeRoyal 71-0031 is a device classified as Class I in the EU and Class II in the US made by Pergo Medikal Ve Ilac Sanayi Anonim Sirketi, registered in EUDAMED on 15 Apr 2026 (Basic UDI-DI 8682952411176BQ) and listed in FDA GUDID since 7 May 2025 (UDI-DI 08682952417390), active as of 24 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8682952411176BQ Basic UDI-DI 08682952417390UDI-DIDate15 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08682952417390 UDI-DI Date7 May 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 8682952411176BQ registered 15 Apr 2026 Active
  • FDA GUDID UDI-DI 08682952417390 listed 7 May 2025 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 08682952417390
  2. Registered EUDAMED 8682952411176BQ

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
DeRoyal
Generic name
Surgical suction system collection container, reusable
Device name
Suction Liner System and Accessories
Model / reference
71-0031
Primary DI / UDI-DI
08682952417390
Basic UDI-DI
8682952411176BQ
FDA product code
GCX
EMDN code
A0601010299 Drainage systems with adjustable suction - other
GMDN term
Surgical suction system collection container, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.6740
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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

Related devices

Category: Surgical suction system collection container, reusable

Similar devices in this category

Other devices filed under DRAINAGE SYSTEMS WITH ADJUSTABLE SUCTION.

Other devices from Pergo Medikal Ve Ilac Sanayi Anonim Sirketi

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Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)