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StarFormer

by FOTONA, proizvodnja optoelektronskih naprav d.o.o.

Ref M008-3T

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

CE MDR 510(k)

Valid until

21 Sep 2027

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier 3EC International a.s.

510(k) K241785↗

+1 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3830054230006SB Basic UDI-DI 03830054237728UDI-DIDate17 Oct 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK241785 Date27 Mar 2025IssuedStatusActive
United StatesGUDID listing GUDID Number03830054237728 UDI-DI Date30 Jul 2024ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2022-MDR/QS-021/A Expiring Expires in 322 days

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    26 Sep 2023
    Expires
    21 Sep 2027

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic Name
Deep-tissue electromagnetic stimulation system, professional
Model / Reference
M008-3T
Primary DI / UDI-DI
03830054237728
Basic UDI-DI
3830054230006SB
510(k) Number
FDA Product Code
IPF, NGX, KPI, QPL
EMDN Code
Z120606 Magnetotherapy equipment
GMDN Term
Deep-tissue electromagnetic stimulation system, professional
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
890.5850, 876.5320, 882.5890
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
SI-MF-000000126

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Properties

  • Serial Number
  • Manufacturing Date

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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No