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Bovie 0002

by Aspen Surgical Products, Inc.

Ref 0002

Bovie 0002 is a Class I device made by Aspen Surgical Products, Inc., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI 0887482EyeBubbleFL) and listed in FDA GUDID since 31 Aug 2026 (UDI-DI 00840113242429), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0887482EyeBubbleFL Basic UDI-DI 00840113242429UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840113242429 UDI-DI Date31 Aug 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0887482EyeBubbleFL registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI 00840113242429 listed 31 Aug 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00840113242429
  2. Registered EUDAMED 0887482EyeBubbleFL

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  • Withdrawn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
Bovie® EUDAMED
Bovie GUDID
Generic name
Eye mask
Model / reference
0002
Primary DI / UDI-DI
00840113242429
Basic UDI-DI
0887482EyeBubbleFL
FDA product code
HOY
EMDN code
T0399 Protection devices (excluding personal protective equipment PPE) - other
GMDN term
Eye mask
Device class
Class I
Regulation number
886.4750
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under PROTECTION DEVICES (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE) - OTHER.

Other devices from Aspen Surgical Products, Inc.

See all devices from Aspen Surgical Products, Inc. →

Properties

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