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Remote Wave Electrode

by BionIT Labs S.r.l. Italy EUDAMED510(k)GUDID

Ref AE03-60-01Model AE02-NN-WW510(k) K260453

Product code GXYEMDN N010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08057971594795 UDI-DIDate20 Mar 2026ListedStatusIn distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK260453 Date12 Mar 2026ClearedStatusActive
European UnionCE/MDR EUDAMED Number805797159AEXX Basic UDI-DIDate16 Dec 2022RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Recalls: none on record (FDA, checked 23 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 23 Oct 2026

Generic Name
Myoelectric hand prosthesis
Model / Reference
AE02-NN-WW EUDAMED
AE03-60-01 EUDAMED
AE03-60 GUDID
Primary DI / UDI-DI
08057971594795, 08057971594801, 08057971594818, 08057971594733
Basic UDI-DI
805797159AEXX
Direct Marketing DI
08057971594795
08057971594801
08057971594818
08057971594733
510(k) Number
FDA Product Code
GXY, IQZ
EMDN Code
N010101 Electromyographic electrodes
GMDN Term
Myoelectric hand prosthesis
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
882.1320, 890.3420
Market of Registration
Italy
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
AE02-NN-WW
AE03-60-01
GUDID
AE03-60
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
IT-MF-000007793
FDA applicant
Bionit Labs Srl

Other devices from BionIT Labs S.r.l.

See all devices from BionIT Labs S.r.l. →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Serial Number
Other properties (22)
  • 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
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (9)

  • EUDAMED 8ea9c041-a1be-4130-8755-96c21bfdad7b 85 fields · synced 22 Oct 2026
  • EUDAMED 08057971594801|805797159AEXX 61 fields · synced 17 May 2026
  • EUDAMED 08057971594818|805797159AEXX 61 fields · synced 18 May 2026
  • EUDAMED 08057971594733|805797159AEXX 61 fields · synced 19 May 2026
  • FDA UDI 46a3f5de-2a2b-48fc-940f-6524f7068004 36 fields · synced 23 Oct 2026
  • FDA UDI 628ea23a-dad9-4e6a-b3a3-49f1a758f3ee 36 fields · synced 23 Oct 2026
  • FDA UDI 892ad642-71b0-4122-aa3f-6272f20ddb24 36 fields · synced 23 Oct 2026
  • FDA UDI 3d54b529-825f-42b9-b6ae-cd32572bf65b 36 fields · synced 23 Oct 2026
  • FDA 510(k) K260453 1 fields · synced 18 May 2026