Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3036834029

FEI Number

3036834029

Entity Name

SHL HEALTHCARE EAD

City/State/Country

Sofia Sofia-Grad, BG

Establishment Address

Zaharna Fabrika District, 1 Kukush Street, Sofia Sofia-Grad 1345, BG

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SHL Healthcare EAD (Owner Number: 10092628)

Owner / Operator Contact Address

Zaharna Fabrika District, 1 Kukush Street, Sofia, BG-23 1345, BG

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FLOJAC B-FLOJAC39

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FNG	Lift, Patient, Ac-Powered	General Hospital	Class 2	880.5500	2025-01-29
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2025-12-08

Official Correspondent

Joakim Arwidson

US Agent Details

James Haynes Email: James.Haynes@shl-medical.com Phone: (954) 7252046

Related Public Records

Same Entity

SHL Healthcare EAD

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
K912769	Century Manufacturing Co.	PATIENT LIFT AND TRANSPORT	1991-10-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2018	Handicare Usa Inc	1	PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Z-0014-2018	Handicare AB Maskinvagen	1	Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009

Similar Registrations

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1062191	Inovo Inc.	Lehigh Acres, FL, US
2428983	GF Health Products, Inc	Atlanta, GA, US
3007031002	KANGHUI MEDICAL TECHNOLOGY (SUZHOU) CO.,LTD	Suzhou Jiangsu, CN
3035641505	BEST HOPEFUL INDUSTRIAL DEVELOPMENT LTD.	HONG KONG, HK
9616086	DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.	TIJUANA Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3036834029. Last updated year: 2026. Please use registration number 3036834029 when referencing this establishment in official correspondence.