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Comby EEG cap with 22 Ag/AgCl electrodes, size 57-62, green

by Pamel d.o.o.

Part of a family of 76 devices: see the family page

Ref CEC1225762Model COMBY EEG CAP

Comby EEG cap with 22 Ag/AgCl electrodes, size 57-62, green (CEC1225762) is an electroencephalographic electrode cap (EU MDR Class I; FDA Class II; FDA product code GXY, Electrode, Cutaneous) made by PAMEL d.o.o., registered in EUDAMED on 14 Sep 2022 (Basic UDI-DI 385889415COMBYEEGCAPPP), cleared under FDA 510(k) K211315 on 9 Nov 2021 and listed in FDA GUDID since 16 Aug 2022 (UDI-DI 03858894151974), active as of 22 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211315

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number385889415COMBYEEGCAPPP Basic UDI-DI 03858894151974UDI-DIDate14 Sep 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number03858894151974 UDI-DI Date16 Aug 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK211315 Date9 Nov 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 385889415COMBYEEGCAPPP registered 14 Sep 2022 Active
  • FDA 510(k) K211315 decided 9 Nov 2021 Active
  • FDA GUDID UDI-DI 03858894151974 listed 16 Aug 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K211315
  2. Listed FDA GUDID 03858894151974
  3. Registered EUDAMED 385889415COMBYEEGCAPPP

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Comby EEG cap with 22 Ag/AgCl electrodes, size 57-62, green EUDAMED
Comby EEG Cap GUDID
Generic name
Electroencephalographic electrode cap, reusable
Device name
Comby EEG Cap with 5 AG/Agcl El.
Model / Ref / Catalog
COMBY EEG CAP, CEC1225762, Comby EEG Cap/ 22 Ag/AgCl EL.
Primary DI / UDI-DI
03858894151974
Basic UDI-DI
385889415COMBYEEGCAPPP
Direct marketing DI
03858894151974
510(k) Number
FDA product code
GXY
EMDN code
N01010203 EEG headsets
GMDN term
Electroencephalographic electrode cap, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.1320
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Croatia
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
COMBY EEG CAP
CEC1225762
GUDID
Comby EEG Cap/ 22 Ag/AgCl EL.
Device classEUDAMED
Class I
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
HR-MF-000028336

Similar devices in this category

Other devices filed under ELECTROENCEPHALOGRAPHIC ELECTRODES.

Other devices from PAMEL d.o.o.

See all devices from PAMEL d.o.o. →

Properties

  • Reprocessed single-use device
  • Measuring function
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)