Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012329712

FEI Number

3012329712

Entity Name

ENCHANT TEK CO. LTD.

City/State/Country

Dongshan Township, Yilan County Taipei, TW

Establishment Address

No. 210 Xiangzhong Rd., Dongshan Township, Yilan County Taipei 26950, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Enchant Tek Co. Ltd. (Owner Number: 10051441)

Owner / Operator Contact Address

No. 210 Xiangzhong Rd., Dongshan Township, Yilan County, TW-NOTA 26950, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242354

PMA Number

N/A

All Registered Proprietary Names

AllPEP 3M Dental Floss Pick 3M Fine Slide Flosser 3M ESPE Floss and Toss 3M Toothbrush Mouthpiece Allfow Pulmonary Function Filter AllNEB

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2024-04-24
JES	Floss, Dental	Dental	Class 1	872.6390	2016-10-19
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2016-10-19
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2016-03-18
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2016-03-18
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2025-11-21

Official Correspondent

Mu Hua Huang

US Agent Details

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

Related Public Records

Same Entity

Enchant Tek 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
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07

Similar Registrations

Registration Number	Establishment Name	Location
3018783526	CEVA LOGISTICS NETHERLANDS BV (Venray)	Oostrum Limburgh, NL
3000126629	Philips Electronics Ltd	Mississauga Ontario, CA
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US
1526863	ICU Medical, Inc.	DUBLIN, OH, US
3002808458	VITALOGRAPH IRELAND LTD.	Co Clare, IE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012329712. Last updated year: 2026. Please use registration number 3012329712 when referencing this establishment in official correspondence.