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DNAP Electrode

by Ad-Tech Medical Instrument Corporation

510(k) K152547Ref DNAP-01-05X

DNAP Electrode is a device classified as Class III in the EU and Class II in the US made by Ad-Tech Medical Instrument Corporation, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI B-00841823106629), cleared under FDA 510(k) K152547 on 4 Mar 2016 and listed in FDA GUDID since 3 Oct 2016 (UDI-DI 00841823106629), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K152547↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00841823106629 Basic UDI-DI 00841823106629UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841823106629 UDI-DI Date3 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK152547 Date4 Mar 2016ClearedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00841823106629 registered 5 Nov 2026 Active
  • FDA 510(k) K152547 decided 4 Mar 2016 Active
  • FDA GUDID UDI-DI 00841823106629 listed 3 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K152547
  2. Listed FDA GUDID 00841823106629
  3. Registered EUDAMED B-00841823106629

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Generic name
Cortical electrode
Device name
Cranial Nerve Electrode
Model / Ref / Catalog
DNAP-01-05X
Primary DI / UDI-DI
00841823106629
Basic UDI-DI
B-00841823106629
510(k) Number
FDA product code
GZL 510(k)
GYC GUDID
EMDN code
N010101 Electromyographic electrodes
GMDN term
Cortical electrode
Device class
Class III EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 882.1330 510(k)
882.1310 GUDID
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 3 fields differ

FieldEUDAMED510(k)GUDID
FDA product codeEUDAMED
—
510(k)
GZL
GUDID
GYC
Device classEUDAMED
Class III
510(k)
Class II
GUDID
Class II
Regulation numberEUDAMED
—
510(k)
882.1330
GUDID
882.1310

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K152547

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K152547
UDI-DISize and differences
DNAP Electrode DNAP-01-05X
Ad-Tech Medical Instrument Corp.
DNAP-01-05X / DNAP-01-05X00841823106629 —On the market

Similar devices in this category

Other devices filed under ELECTROMYOGRAPHIC ELECTRODES.

Other devices from Ad-Tech Medical Instrument Corp.

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

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)