Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616791

FEI Number

3001316486

Entity Name

Waismed Ltd.

City/State/Country

Rosh Haayin Central, IL

Establishment Address

10 Amal St., Afek Industrial Park, Rosh Haayin Central 4809234, IL

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Safeguard US Operating LLC (Owner Number: 9024805)

Owner / Operator Contact Address

13359 Reese Blvd. E., Huntersville, NC 28078, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

B.I.G. Pediatric B.I.G NIO Adult NIO Infant NIO Fixation B.I.G. Adult NIO Pediatric GO-IO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	1999-02-04
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2008-10-22
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2015-05-14
MHC	Needle, Interosseous	General Hospital	Class 2	880.5570	2019-10-28
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-10-28
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2015-09-01
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	1999-02-04
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-06-27
OJA	Intravenous Extension Tubing Set	General Hospital	Class 2	880.5440	2016-01-25

Official Correspondent

Kimberly Reed

US Agent Details

Kimberly Reed Business: Safeguard US Operating Email: kimberlyr@safeguardmedical.com Phone: (855) 4286074

Related Public Records

Same Entity

Safeguard US Operating LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011657181	SAFEGUARD MEDICAL TECHNOLOGIES LTD	Hereford Herefordshire, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616791. Last updated year: 2026. Please use registration number 9616791 when referencing this establishment in official correspondence.