Data / Medical devices / Taiwan / North Eos Industries, Inc.

North Eos Industries, Inc.: FDA-registered device maker in Taichung City, Taiwan, 3 510(k) clearances

Name: North Eos Industries, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

North Eos Industries, Inc. is registered with the FDA (registration 8043235) in Taichung City, Taiwan. It lists 22 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 11, 1996. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch North Eos Industries, Inc.

FDA registration number: 8043235
FEI number: 2981
Address: No. 46, Zhongtai Street Tung-Shih District, Taichung City, Taiwan, 423
Owner or operator: NORTH EOS INDUSTRIES, INC. (8043235)
Roles: Manufacturer
First device listed: November 10, 1993
Registered through: 2026
Brand names listed: DentBox, DentSpec, EOS BEAUTY TRAY, EOS BRAND, EOS BRAND DISPOSABLE, EOS BRAND DISPOSABLE ORAL EXPANDER, EOS BRAND SUCTION, EOS EyelidSpec and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Retractor, Dental	EIF	1	Manufacturer	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Manufacturer	accessdata.fda.gov
Cleanser, Denture, Over The Counter	EFT	1	Manufacturer	accessdata.fda.gov
Curette, Ear	JYG	1	Manufacturer	accessdata.fda.gov
Curette, Nasal	KAP	1	Manufacturer	accessdata.fda.gov
Dilator, Cervical, Fixed Size	HDQ	1	Manufacturer	accessdata.fda.gov
Dilator, Nasal	LWF	1	Manufacturer	accessdata.fda.gov
Endoscope, Ac-Powered And Accessories	GCP	2	Manufacturer	accessdata.fda.gov
Expander, Surgical, Skin Graft	FZW	1	Manufacturer	accessdata.fda.gov
Gag, Mouth	KBN	1	Manufacturer	accessdata.fda.gov
Illuminator, Color Vision Plate	HJD	1	Manufacturer	accessdata.fda.gov
Otoscope	ERA	1	Manufacturer	accessdata.fda.gov
Remover, Intrauterine Device, Contraceptive, Hook-Type	HHF	1	Manufacturer	accessdata.fda.gov
Retractor, Ophthalmic	HNI	1	Manufacturer	accessdata.fda.gov
Sound, Uterine	HHM	1	Manufacturer	accessdata.fda.gov
Spatula, Cervical, Cytological	HHT	2	Manufacturer	accessdata.fda.gov
Speculum, Ent	EPY	1	Manufacturer	accessdata.fda.gov
Speculum, Rectal	FFQ	1	Manufacturer	accessdata.fda.gov
Speculum, Vaginal, Nonmetal	HIB	2	Manufacturer	accessdata.fda.gov
Stethoscope, Fetal	HGN	1	Manufacturer	accessdata.fda.gov
Transilluminator, Battery-Powered	HJN	1	Manufacturer	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 11, 1996	K963685	EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER	HHT	Substantially Equivalent	North Eos Industries, Inc.	accessdata.fda.gov
October 4, 1996	K963377	EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC	HIB	Substantially Equivalent	North Eos Industries, Inc.	accessdata.fda.gov
April 10, 1996	K954614	EOS BRAND DISPOSABLE PROCTOSCOPE	GCP	Substantially Equivalent	North Eos Industries, Inc.	accessdata.fda.gov

Compare with other makers

Updated October 11, 1996. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.