Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010806663

FEI Number

3010806663

Entity Name

INORIS MEDICAL SP. Z O.O.

City/State/Country

Kowary Dolnoslaskie, PL

Establishment Address

ul. Zmkowa 9, Kowary Dolnoslaskie 58530, PL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Inoris Medical Sp. z o.o. (Owner Number: 10046303)

Owner / Operator Contact Address

ul. Zmkowa 9, Kowary, PL-02 58-530, PL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191858

PMA Number

N/A

All Registered Proprietary Names

Adult Biteguard Scanhead protection cover Gastroguard Clip-On Biteguard Pediatric Biteguard Soft Adult Biteguard Tubeguard PYLANT MONITOR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2014-03-03
BSK	Cuff, Tracheal Tube, Inflatable	Anesthesiology	Class 2	868.5750	2020-08-12

Official Correspondent

Pawel Gotowala

US Agent Details

Robert Kaliski Business: KAL-MED, LLC Email: contact@kalmed.net Phone: (585) 6334225

Related Public Records

Same Entity

Inoris Medical Sp. z o.o.

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-0006-2014	H & H Associates	2	H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part *H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708*. The product is used to maintain fracture alignment.

Similar Registrations

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9681702	BATRIK MEDICAL MANUFACTURING INC.	Lachine Quebec, CA
3014926389	Jiangsu JianYu Health Medical Co., Ltd	Changzhou City Jiangsu, CN
3004930567	SUZHOU SUNING UNDERPAD CO., LTD.	SUZHOU, JIANGSU PROVINCE, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010806663. Last updated year: 2026. Please use registration number 3010806663 when referencing this establishment in official correspondence.