Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011213495

FEI Number

3011213495

Entity Name

INOVYTEC MEDICAL SOLUTIONS LTD.

City/State/Country

Raanana Central, IL

Establishment Address

5 HaTidhar St., Industrial Zone, Raanana Central 4366507, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Inovytec Medical Solutions Ltd. (Owner Number: 10047253)

Owner / Operator Contact Address

5 HaTidhar St., Industrial Zone, Raanana, IL-NOTA 4366507, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Lubo Airway Collar Mini Lubo Airway Collar VWSP-370 VWSP-390

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2014-07-28
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2024-09-20

Official Correspondent

Udi Kantor

US Agent Details

Matt Dryden Business: ProMedic, LLC Email: matt.dryden@promedic.cc Phone: (239) 3076063

Related Public Records

Same Entity

Inovytec Medical Solutions Ltd.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Z-0031-2026	Percussionaire Corporation	1	Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use

Similar Registrations

Registration Number	Establishment Name	Location
3031583032	NINGBO LANDING TECHNOLOGY COMPANY CO., LTD.	Ningbo Zhejiang, CN
2242467	HAUSMANN ENTERPRISES, LLC	NORTHVALE, NJ, US
3008261717	XIAMEN COMPOWER MEDICAL TECH. CO., LTD.	Xiamen Fujian, CN
3010260768	VTS ONE MEMBER CO., Ltd.	Hai Phong City, VN
3011556461	COMFORT PLUS CORPORATION	New Taipei City, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011213495. Last updated year: 2026. Please use registration number 3011213495 when referencing this establishment in official correspondence.