Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004065038

FEI Number

3004065038

Entity Name

RONDISH COMPANY LIMITED

City/State/Country

KWAI CHUNG, NT, HONG KONG, HK

Establishment Address

UNIT G & H, 4/F, BLK 1, KWAI TAK IND CTR, 15-33 KWAI TAK ST., KWAI CHUNG, NT, HONG KONG --, HK

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

RONDISH COMPANY LIMITED (Owner Number: 9057545)

Owner / Operator Contact Address

UNIT G & H, 4/F, BLK 1, KWAI TAK IND CTR, 15-33 KWAI TAK STREET, KWAI CHUNG, N.T., HK-NOTA 0000, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

UFBP-20 TM-12B-U Patient Handset (NEC-12) Pullstring magnet alarm w/out Nursecall, w/ low batt LED CSP-B18MO-TU10 CSM-BC300-UN CSM-BC600-UN CSM-BC400-UN DMT-21 CSP-B18MO-TW10 Universal Transmitter (UT-11) WCP-11C CSP-TW-TX1 CSP-C18MO-TC10-92 CSM-PM100-UN Universal Floormat (CS-FMS-2448-UN) Alarm w/ AC port, Lost-find, no Nursecall + use/low batt LED TXP-11(V2) CSP-C18MO-TC10-34 Pager (PAG-31) CSP-EC-72 ZP-01(S) SF574 WCP-11 CSM-BC400-L CSP-PT-11 CSP-SBP-10-10PK NGM-41 SF572 CSP-SCB-07 CSP-C18MO-TW10 Under-Mattress Sensor Pad (CSP-UM) CSP-SNP-CAB-92 CSP-TW-TX45DY CS-FMS-2448-UN Receiver Dongle (DON-40) NC570 SF570 Receiver Dongle (DON-30) Replacement cord & new design encased magnet for alarms Pullstring encased magnet alarm w/ Nursecall, low batt LED Alarm w/out CPI, Pad-Detect, w/ use/batt alarm, Nursecall Indication Light Bumper (ILB-21) NC571 CSP-B18MO-TC10-92 Wristband Transmitter (TXP-11(V2)) CSP-SNP-CAB-34 CSP-TW-TX18MO-R1 CSP-C18MO-TU10 Early Alert Bed Sensor Pad (WPAS-10) CSM-BC201-UN CSP-TS-1 Bathroom Pull Cord (WCP-11) Wireless PIR w/ wall mount SF571 CSP-TW-TX18MO UT-11 CSP-SBP-10 Bedhead Call Point (WCP-11C) Replacement cord & magnet for alarms SF573 CSM-BC100-UN TXP-21 CSP-B14-NC4-10PK NEC-05M NGM-21 CS-FMS-C2448 CSP-C30-NC10-10PK CS-SB2054V CSP-SCP-07-10PK CS-WMS ILB-21-FSK Alarm - voice/CPI/AC in/Nursecall/PadChange/use/low bat LED ZP-01(M) CSP-C14-NC7-10PK DMS-21 Wireless Door and Window Sensor (CS-WDWS) Non-slip pad DON-30-FSK AC-06 UMBP-10-U

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2003-07-22

Official Correspondent

STEVEN WILLIAMS

US Agent Details

Michael Dunphy Email: mpdunphy@gmail.com Phone: (541) 6009812

Related Public Records

Same Entity

RONDISH COMPANY LIMITED

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004065038. Last updated year: 2026. Please use registration number 3004065038 when referencing this establishment in official correspondence.