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SweatC A001

by LD Technology

Ref A001

SweatC A001 is a device classified as Class IIa in the EU and Class II in the US made by LD Technology, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI 08600135619SCWA), cleared under FDA 510(k) K152216 on 24 Sep 2015 and listed in FDA GUDID since 12 Mar 2019 (UDI-DI 00860013561918), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K152216

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08600135619SCWA Basic UDI-DI 00860013561918UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00860013561918 UDI-DI Date12 Mar 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK152216 Date24 Sep 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08600135619SCWA registered 26 Oct 2026 Active
  • FDA 510(k) K152216 decided 24 Sep 2015 Active
  • FDA GUDID UDI-DI 00860013561918 listed 12 Mar 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K152216
  2. Listed FDA GUDID 00860013561918
  3. Registered EUDAMED 08600135619SCWA

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  • Withdrawn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
LD Technology EUDAMED
SweatC GUDID
Generic name
Skin electrical conductance meter
Model / reference
A001
Primary DI / UDI-DI
00860013561918 EUDAMED
B322A0011 GUDID
Basic UDI-DI
08600135619SCWA
510(k) Number
FDA product code
GZO
EMDN code
Z12040102 Equipment for analysis of the physiological parameters of the skin
GMDN term
Skin electrical conductance meter
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.1540
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00860013561918
GUDID
B322A0011
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00860013561918; FDA GUDID lists B322A0011), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Skin electrical conductance meter

Similar devices in this category

Other devices filed under GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS.

Other devices from LD Technology

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Properties

  • Measuring function
  • Lot / batch number
  • Serial number
Other properties (22, all answered No)