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Operace 80296

by Pb Swiss Tools AG

Ref 80296

Operace 80296 is a device classified as Class IIa in the EU and Class I in the US made by Pb Swiss Tools AG, registered in EUDAMED on 25 Jun 2026 (Basic UDI-DI 7610733MD64122B7) and listed in FDA GUDID since 24 Sep 2024 (UDI-DI 07610733802968), 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7610733MD64122B7 Basic UDI-DI 07610733802968UDI-DIDate25 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07610733802968 UDI-DI Date24 Sep 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 7610733MD64122B7 registered 25 Jun 2026 Active
  • FDA GUDID UDI-DI 07610733802968 listed 24 Sep 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07610733802968
  2. Registered EUDAMED 7610733MD64122B7

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  • Withdrawn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
Operace
Generic name
Surgical screwdriver trial
Device name
Screw Recess Trials
Model / Ref / Catalog
80296
Primary DI / UDI-DI
07610733802968 EUDAMED
07610733852963 GUDID
Basic UDI-DI
7610733MD64122B7
FDA product code
HXB
EMDN code
V9012 Non-specialist surgical instruments and kits, single-use
GMDN term
Surgical screwdriver trial
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
07610733802968
GUDID
07610733852963
Device classEUDAMED
Class IIa
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists 07610733802968; FDA GUDID lists 07610733852963), 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.

Related devices

Category: Surgical screwdriver trial

Similar devices

Also classified as Surgical screwdriver trial.

Similar devices in this category

Other devices filed under NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE.

Other devices from Pb Swiss Tools AG

See all devices from Pb Swiss Tools AG →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)