Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3045010542

FEI Number

3045010542

Entity Name

WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd.

City/State/Country

Huizhou Guangdong, CN

Establishment Address

6th, 7th, and 8th Floors of Building 11,6th and 7th Floors of Building 10,No.18 Binhe Avenue,Lilin Town, Zhongkai High-Tech Zone, Huizhou Guangdong 516035, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Wickimed Supply Co., Ltd. (Owner Number: 10029747)

Owner / Operator Contact Address

Room317, 3/F, Genplas Industrial Bldg,, 56 Hoi Yuen Road, Kwun Tong., Hong Kong, HK-NOTA None, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

45 degree TUNGSTEN MICRONEEDLE(Model:138504,138504-10) Electrosurgical Pencil with electrode,model:WP200,WP200-B100S,WP200-C100S,WP200-L31S,WP200-N100S,WP200-B90S 3cm TUNGSTEN MICRONEEDLE(Model:138505,138505-10) 4cm TUNGSTEN MICRONEEDLE(Model:138506,138506-10)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-09-15
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2025-10-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-10-29
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2019-09-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-09-18

Official Correspondent

Mac Lai

US Agent Details

DAVID LENNARZ Business: REGISTRAR CORP Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Wickimed Supply Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3020142587	WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd.	HuiZhou Guangdong, CN
3010601992	Wickimed(Huizhou)Medical Equipment Manufacturing Co.,Ltd.	Huizhou Guangdong, CN
3007710878	Wickimed Supply Company Limited .	Hong Kong, HK

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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3012940012	Sutter Medical Technologies USA Inc.	Alpharetta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3045010542. Last updated year: 2026. Please use registration number 3045010542 when referencing this establishment in official correspondence.