Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003080184

FEI Number

3003080184

Entity Name

BEYONICS INTERNATIONAL PTE. LTD.

City/State/Country

SINGAPORE North West, SG

Establishment Address

51 Marsiling Road, SINGAPORE North West 739114, SG

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BEYONICS TECHNOLOGY LTD. (Owner Number: 9047622)

Owner / Operator Contact Address

51 Marsiling Road, SINGAPORE, SG-NOTA 739114, SG

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SpineGuard SpineGuard

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2012-12-17
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2015-06-26
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2015-06-26

Official Correspondent

No official correspondent registered.

US Agent Details

John Yezback Email: johnyezback@beyonics.com Phone: (586) 9957155

Related Public Records

Same Entity

BEYONICS TECHNOLOGY LTD.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880088	Cadwell Laboratories, Inc.	CADWELL EXCEL	1988-05-04
K833646	Edward Weck, Inc.	PULSATRON NERVE LOCATOR/STIMULATOR	1984-02-10
K150005	Ndi Medical, LLC	Checkpoint, Checkpoint Head & Neck	2015-02-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0024-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.

Similar Registrations

Registration Number	Establishment Name	Location
3018708317	MAGNUS MEDICAL INC.	Burlingame, CA, US
1221763	ARCH Medical Solutions - Seabrook	SEABROOK, NH, US
3008773490	PAUL E. DANCHELL A/S	Jyderup Sjalland, DK
9611252	NIHON KOHDEN CORP.	SHINJUKU-KU Tokyo, JP
3009959868	Ferry Machine Corporation	Little Ferry, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003080184. Last updated year: 2026. Please use registration number 3003080184 when referencing this establishment in official correspondence.