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Mtr-Ac-01

by CLASSYS Inc.

Ref MTR-AC-01

Mtr-Ac-01 is a device classified as Class IIb in the EU and Class II in the US made by CLASSYS Inc., registered in EUDAMED on 16 Jun 2026 (Basic UDI-DI B-08800016904246), cleared under FDA 510(k) K241157 on 21 Nov 2024 and listed in FDA GUDID since 2 Jul 2025 (UDI-DI 08800016904246), active as of 25 Oct 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241157

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800016904246 Basic UDI-DI 08800016904246UDI-DIDate16 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800016904246 UDI-DI Date2 Jul 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK241157 Date21 Nov 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800016904246 registered 16 Jun 2026 Active
  • FDA 510(k) K241157 decided 21 Nov 2024 Active
  • FDA GUDID UDI-DI 08800016904246 listed 2 Jul 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K241157
  2. Listed FDA GUDID 08800016904246
  3. Registered EUDAMED B-08800016904246

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  • Withdrawn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 · GUDID

Generic name
Open-surgery electrosurgical electrode, monopolar, single-use
Device name
Sterile micro needle electrodes
Model / reference
MTR-AC-01
Primary DI / UDI-DI
08800016904246
Basic UDI-DI
B-08800016904246
510(k) Number
FDA product code
GEI
EMDN code
K0201010301 Open electrosurgery electrodes, single-use
GMDN term
Open-surgery electrosurgical electrode, monopolar, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Open-surgery electrosurgical electrode, monopolar, single-use

Cleared under the same submission (K241157)

and 8 more cleared under K241157

Similar devices in this category

Other devices filed under OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE.

Other devices from CLASSYS Inc.

See all devices from CLASSYS Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)