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Bipolar Cord

by DeRoyal Industries, Inc. 2 variants

Ref 88-101000

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0749756N157E1JN Basic UDI-DI 00749756136297UDI-DIDate1 Oct 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00749756136297 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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
Bipolar Cord EUDAMED
DeRoyal GUDID
Generic Name
Endoscopic electrosurgical electrode, bipolar, single-use
Model / Reference
88-101000
Primary DI / UDI-DI
00749756136297
Basic UDI-DI
0749756N157E1JN
FDA Product Code
GEI
EMDN Code
V9099 Various devices not included in other classes - other
GMDN Term
Endoscopic electrosurgical electrode, bipolar, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
878.4400
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000002102
Authorised representative
MedEnvoy Global BV NL-AR-000024028

Related devices

Category: Device sterilization/disinfection container, reusable

Other devices from Deroyal Industries, Inc.

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Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (20)

  • Sterile: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No