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Placement Stay Flange

by Ad-Tech Medical Instrument Corp.

Ref FLANGE-X

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 Number08418231RA11bBW Basic UDI-DI 00841823103499UDI-DIDate2 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841823103499 UDI-DI Date17 Sep 2018ListedStatusListed 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  • Withdrawn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

Generic Name
Neurosurgical procedure kit, non-medicated, single-use
Device Name
Placement and Accessories – Class Is/Im Devices
Model / Ref / Catalog
FLANGE-X
Primary DI / UDI-DI
00841823103499
Basic UDI-DI
08418231RA11bBW
FDA Product Code
GZL
EMDN Code
N010180 Neurophysiology devices - accessories
GMDN Term
Neurosurgical procedure kit, non-medicated, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
882.1330
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000004795
Authorised representative
E C REP LIMITED IE-AR-000003995

Other devices from Ad-Tech Medical Instrument Corp.

See all devices from Ad-Tech Medical Instrument Corp. →

Properties

  • Sterile
  • Single Use
  • Reusable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Implantable: 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
  • Manufacturing Date: No