Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026326493

FEI Number

3026326493

Entity Name

ZHEJIANG YAMEI MEDICAL EQUIPMENT TECHNOLOGY CO., LTD.

City/State/Country

Yang Jiao Lang Zin'an Town Zhejiang, CN

Establishment Address

17#-01 Zhongnan high tech - Yuhhe Zhigu Industriak Park, Yang Jiao Lang Zin'an Town Zhejiang 313212, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhejiang Yamei Medical Equipment Technology Co., Ltd. (Owner Number: 10087161)

Owner / Operator Contact Address

17#-01 Zhongnan high tech - Yuhhe Zhigu Industriak Park, Yang Jiao Lang Zin'an Town, CN-ZJ 313212, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Forceps Micro Applicator Saliva Ejector X-Ray Holder Surgical Aspirator Tip Medical Face Shield Band.Material. Orthodontic Disposable Air-Water Syringe Tips, Cover Of Air-Water Syringe Tips,Curved Utility Syringes, HP Mixing Tip Spatular Band, Elastic, Orthodontic Braces Hook,Braces Chewies Retainer, Screw Expansion, Orthodontic Mouth Props, Endo Measure Block,Endo Clean Stand Mouth Mirror, Contrastor, Photographic Mirror Denture Brush Impression Tray Base,Impression Tray Dental Instrument Tray, Holder Of Medicine Bottle, Dental Bib Holder, Denture Transportation Box, Endo Sponge/Cushions Bur Holder/Box/Dispenser, Cotton Roll Dispenser, Cotton Roll, Dental Bib, Surgical Blade Medical Eye Shield Prophy Cup Brush Universal Barrier Film,Denture Box Dental Probe Instrument Steri Container Prophy Paste Mixing Bowl, Silicone Rubber Cup, Plastic Dappen Dish, Mortar And Pestle, Medicine Bottle, Glass Dappen Dish

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2024-12-30
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2024-12-30
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2024-12-30
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2024-12-30
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2024-12-30
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2024-12-30
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	2024-12-30
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2024-12-30
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-12-30
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2023-01-19
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-12-30
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2023-01-19
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2024-12-30
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2024-12-30
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2024-12-30
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2024-12-30
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-12-30
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2024-12-30
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2024-12-30
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2024-12-30
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2023-01-19
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2024-12-30
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-12-30
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2023-01-19
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2024-12-30
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2024-12-30
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2023-01-19
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2023-01-19

Official Correspondent

No official correspondent registered.

US Agent Details

Fanfei Liu Email: U.S.agent@frosatechnology.com Phone: (346) 7358880

Related Public Records

Same Entity

Zhejiang Yamei Medical Equipment Technology 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
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2012	Biomet Microfixation, Inc.	1	Biomet Microfixation outer packaging labeled in part:"REF: SP-2411*RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com." Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USAMediMark Europe BP2332 F-38033 Grenoble Cedex 2. FranceLOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN**" Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire.
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

Similar Registrations

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026326493. Last updated year: 2026. Please use registration number 3026326493 when referencing this establishment in official correspondence.