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Accu-Temp® 8445000

by Beaver-Visitec International Inc

Ref 8445000

Accu-Temp® 8445000 is a device classified as Class IIb in the EU and Class II in the US made by Beaver-Visitec International Inc, registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI B-00886158010296) and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00886158010296), active as of 8 Nov 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 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00886158010296 Basic UDI-DI 00886158010296UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886158010296 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00886158010296 registered 7 Oct 2026 Active
  • FDA GUDID UDI-DI 00886158010296 listed 19 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886158010296
  2. Registered EUDAMED B-00886158010296

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  • Withdrawn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
Accu-Temp®
Generic name
Electrocautery system generator, battery-powered
Device name
Ophthalmic Accu-Temp® Cautery
Model / reference
8445000
Primary DI / UDI-DI
00886158010296 EUDAMED
30886158010297 GUDID
Basic UDI-DI
B-00886158010296
FDA product code
HQP
EMDN code
Q021199 Ophthalmic surgery instruments, single-use - other
GMDN term
Electrocautery system generator, battery-powered
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
886.4115
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00886158010296
GUDID
30886158010297
Device classEUDAMED
Class IIb
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00886158010296; FDA GUDID lists 30886158010297), so their flags are not compared. Device class is stated on each registry's own scale: Class IIb 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: Electrocautery system generator, battery-powered

Similar devices in this category

Other devices filed under OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Beaver-Visitec International Inc

See all devices from Beaver-Visitec International Inc →

Properties

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