Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009771213

FEI Number

3009771213

Entity Name

OMNIMATE ENTERPRISE CO., LTD.

City/State/Country

Ilan County Yilan, TW

Establishment Address

No.8, Lane 126, Sec. 2, Ligong 1st Rd., Wuchieh Hsiang, Ilan County Yilan 26841, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Omnimate Enterprise Co., LTD. (Owner Number: 10041736)

Owner / Operator Contact Address

No.8, Ln. 126, Sec. 2, Ligong 1st Rd., Wujie Township, Yilan County, TW-ILA 26841, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Single Use Handheld Suction Device Nasopharyngeal Airway SnapBlock Nasal Cannula GuideBlade Non-Rebreathing Mask NeVap ASSET Laryngeal Mask Airway Tulip Airway Device TOAD LIVVE Oral Airway PROWAY Oropharyngeal Airway TOAD Big Mouth Oral Airway with Balloon Sure Spec vaginal speculum

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2024-02-01
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2012-08-27
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2023-12-13
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2016-04-28
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2019-09-10
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2022-08-01
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2012-08-27
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2019-06-06
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2019-06-06
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2012-08-27
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2024-05-13

Official Correspondent

Sarah Shan

US Agent Details

Benjamin Richard Wang Business: NEVAP Inc. Email: Benjaminrwang@gmail.com Phone: (408) 3985159

Related Public Records

Same Entity

Omnimate Enterprise Co., 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
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23
K142298	Covidien	Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff	2015-02-13
K182861	Covidien	Shiley Neonatal/Pediatric Tracheostomy Tube	2019-03-22
K142296	Covidien	Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula	2015-02-24
K233341	Covidien, LLC	Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)	2024-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH
Z-0024-04	Vital Concepts, Inc.	1	Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009771213. Last updated year: 2026. Please use registration number 3009771213 when referencing this establishment in official correspondence.