Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616482

FEI Number

3003188701

Entity Name

SAFEGARD MEDICAL (HUNGARY), LTD.

City/State/Country

FARKASLYUK Borsod-Abauj-Zemplen, HU

Establishment Address

JOSZERENCSET TER 15, FARKASLYUK Borsod-Abauj-Zemplen H-3608, HU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NUMAN HOLDING LTD (Owner Number: 9039987)

Owner / Operator Contact Address

Palm Chambers,197,Main Street, P.O. Box 3174, Road Town., Tortola, VG-NOTA VG1110, VG

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K012283

PMA Number

N/A

All Registered Proprietary Names

SOLOGARD Locking Plus Syringe with Needle SOLOGARD Two Parts Syringe Without Needle

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	2023-06-07

Official Correspondent

No official correspondent registered.

US Agent Details

Barry Boris Berler Email: deluxeceo1@gmail.com Phone: (215) 2921999

Related Public Records

Same Entity

NUMAN HOLDING 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
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 9616482. Last updated year: 2026. Please use registration number 9616482 when referencing this establishment in official correspondence.