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Bovie DEL0

by Aspen Surgical Products, Inc.

Ref DEL1

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08401132CauteryHRV4 Basic UDI-DI 00840113232857UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840113232857 UDI-DI Date10 Sep 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Electrocautery system generator, battery-powered
Device Name
Bipolar Electrocautery Systems, High Temperature (sterile)
Model / Reference
DEL1 EUDAMED
DEL0 GUDID
Primary DI / UDI-DI
00840113232857
Basic UDI-DI
08401132CauteryHRV4
Direct Marketing DI
00840113232857
FDA Product Code
GEI
EMDN Code
K02010303 High temperature bipolar electrocauters, single use
GMDN Term
Electrocautery system generator, battery-powered
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4400
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
DEL1
GUDID
DEL0
Device ClassEUDAMED
Class IIb
GUDID
Class II

Other devices from Aspen Surgical Products, Inc.

See all devices from Aspen Surgical Products, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No