Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031092085

FEI Number

3031092085

Entity Name

3D GLOBAL BIOTECH INC.

City/State/Country

New Taipei City, TW

Establishment Address

21F.-1, No.99, Sec. 1, Xintai 5th Rd.,, New Taipei City 22175, TW

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

3D Global Biotech Inc. (Owner Number: 10090574)

Owner / Operator Contact Address

21F.-1, No.99, Sec. 1, Xintai 5th Rd.,, New Taipei City, TW-TPE 22175, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ExoMate HairMatt Wound Mate EZ-i Former LensMate ExoLens Wound Mate HairMatt EyeMate ExoLens LensMate ExoMate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KIT	Media And Components, Synthetic Cell And Tissue Culture	Hematology	Class 1	864.2220	2024-04-14
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2025-02-04
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2025-02-04
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2024-05-02

Official Correspondent

Peng Yu-Quan

US Agent Details

Diana Alpin Email: info@duocarepro.com Phone: (626) 4923094

Related Public Records

Same Entity

3D Global Biotech Inc.

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
K832690	Sigma Chemical Co.	MINIMUM ESSENTIAL MED. EAGLE M0268	1983-09-12
K861867	Hazleton Research Products, Inc.	MEM ALPHA EAGLE MEDIUM	1986-05-29
K821916	Dutchland Laboratories, Inc.	IMPROVED MEM-RICHTER'S POWDER MODIF.	1982-07-27
K810767	Dutchland Laboratories, Inc.	RPMI 1640 MEDIUM	1981-05-08
K133079	Alden Optical Labs., Inc.	IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC)	2013-12-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0018-07	Ciba Vision Corporation	2	CSI Daily Wear, soft (hydrophilic) contact lenses
Z-0019-07	Ciba Vision Corporation	2	CSI Flexible Wear, soft (hydrophilic) contact lenses
Z-0020-07	Ciba Vision Corporation	2	CSI Toric, soft (hydrophilic) contact lenses
Z-0044-2012	CooperVision Inc.	2	AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 SOFT CONTACT LENSES FOR ASTIGMATISM, CooperVision, Scottsville, NY 14546 USA; Juana Diaz, PR 00795 USA; Hamble SO31, 4RF, UK; Device Listing # D033736. Product Usage: Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00- to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. The AVAIRA Soft Contact Lens is indicated for single - use disposable wear and daily wear. When prescribed for frequent replacement, the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system.
Z-0326-2026	Alcon Research LLC	2	Alcon PRECISION1 One-Day Contact Lenses, -2.25D.

Similar Registrations

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3042175767	PROSTEM HAIR B.V.	Maastricht Limburg, NL
3035387168	YENI BIYOTEKNOLOJI ANONIM SIRKETI	BALCOVA Izmir, TR
1123137	STERILIZATION SERVICES OF VIRGINIA	RICHMOND, VA, US
3005182157	HIMEDIA LABORATORIES PRIVATE LIMITED	DOMBIVLI, THANE Maharashtra, IN
3008496303	REGEN LAB Sa	LE MONT-SUR-LAUSANNE Vaud, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031092085. Last updated year: 2026. Please use registration number 3031092085 when referencing this establishment in official correspondence.