FEI 3002772487

Rolence Ent. Inc.

18-3 LANE 231 PU CHUNG RD., CHUNGLI Taoyuan, TW

Establishment typeExportExport Device to the United States But Perform No Other Operation on Device

Registered product codes

12 product codes

0 on file

No MDR events on file for this firm name.

0 on file

No recalls on file for this firm name.

Matched by FEI 3002772487.

4 on file

Voluntary Action Indicated (VAI)Sep 25, 2025
Compliance: Devices · Citations posted
Voluntary Action Indicated (VAI)Sep 25, 2025
Radiation Control and Health Safety Act · Citations posted
Official Action Indicated (OAI)Jul 11, 2024
Compliance: Devices · Citations posted
Official Action Indicated (OAI)Jul 11, 2024
Postmarket Assurance: Devices · Citations posted

11 on file

Top cited requirements

21 CFR 1020.30(k)Sep 25, 2025
Compliance measurements--diagnostic source assembly
21 CFR 801.20(a)Jul 11, 2024
Label to bear a unique device identifier
21 CFR 803.17Jul 11, 2024
Lack of Written MDR Procedures
21 CFR 820.30(a)Jul 11, 2024
Design control - no procedures
21 CFR 820.70(a)Jul 11, 2024
Process control procedures, Lack of or inadequate procedures
21 CFR 820.70(i)Jul 11, 2024
Software validation for automated processes
21 CFR 820.80(c)Jul 11, 2024
Lack of or inadequate In-process acceptance procedures
21 CFR 820.100(a)Jul 11, 2024
Lack of or inadequate procedures
21 CFR 820.120Jul 11, 2024
Lack of or inadequate procedures for labeling
21 CFR 820.184Jul 11, 2024
DHR content
21 CFR 820.198(a)Jul 11, 2024
Lack of or inadequate complaint procedures

0 on file

No warning letters or injunctions on file for this FEI number.

0 on file

No import refusals on file for this FEI number.