Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001650535

FEI Number

3001650535

Entity Name

Suzhou Meccan Import and Export Corp.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

53 Ruyuan Rd, Suzhou Jiangsu 215131, CN

Establishment Type(s)

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

Owner / Operator

SUZHOU MECCAN IMP. & EXP. CORPORATION (Owner Number: 9045121)

Owner / Operator Contact Address

5 FL., ZHUHUI COMMERCIAL BLDG., 180 ZHUHUI ROAD, SUZHOU, JIANGSU PROVINCE, CN-NOTA 215006, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

3-Ply Disposable Face Mask MANUAL SURGICAL INSTRUMENTS Shoe Cover Eye Shield EXO-CATHETER Patient Positioning Device, Anesthesia Welmed Bite Strap Synthetic Rubber, LF Curad bandage scissor Medline bandage scissor Infrared Thermometer Surgical Cap Drainage Bag camera cover Waste Management System Non-Sterile Specimen Container Vein Hook Non-surgical isolation gown NONPNEUMATIC Sheets-Drapes / Stand & Equipment Covers / Table skin / small marker PENLIGHT Medline arm/leg sleeve bandage BULKEE II GAUZE SPONGES BANDAGES Needle Counter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPD	Strip, Temperature, Forehead, Liquid Crystal	General Hospital	Class 2	880.2200	2019-03-26
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2004-04-16
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2022-09-20
BXN	Stimulator, Nerve, Battery-Powered	Anesthesiology	Class 2	868.2775	2013-04-16
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-21
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2004-01-06
ILD	Adaptor, Dressing	Physical Medicine	Class 1	890.5050	2015-10-19
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2015-03-25
KHY	Cane, Safety Walk	Physical Medicine	Class 1	890.3075	2018-10-31
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2020-02-21
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2007-05-17
BRW	Protector, Dental	Anesthesiology	Class 1	868.5820	2015-10-19
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2002-08-05
EXJ	Device, Incontinence, Urosheath Type, Sterile	Gastroenterology, Urology	Class 1	876.5250	2003-04-23
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2017-02-22
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2025-12-05
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2019-06-04
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2013-12-05
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2022-09-20
EYJ	Holder, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2014-10-26
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-05-06
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-05-30
EXF	Bag, Bile Collecting	Gastroenterology, Urology	Class 2	876.5010	2020-05-30
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2022-09-09
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2011-07-27
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2010-12-03
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2010-12-03
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2011-07-19
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2020-05-30
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2015-12-01
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2020-05-14
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2015-10-27
GAJ	Stripper, Vein, Disposable	General, Plastic Surgery	Class 1	878.4800	2013-11-19
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-04-29
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-05-29
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2022-09-20
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2013-03-28
LZB	Finger Cot	General Hospital	Class 1	880.6250	2009-12-07
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-04-02
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2007-05-17
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2010-11-19
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2011-07-27
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2005-04-29
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2015-06-29
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2017-01-06
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2014-05-29
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2004-04-08
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2010-09-27
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2017-02-22

Official Correspondent

No official correspondent registered.

US Agent Details

Rosanna Lee Business: Simcon International LLC Email: rlee@simconintl.com Phone: (847) 9492290

Related Public Records

Same Entity

SUZHOU MECCAN IMP. & EXP. CORPORATION

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
K860126	Burron Medical Products, Inc.	STIMUPLEX, NERVE STIMULATOR	1986-02-28
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
K772144	Medline Industries, Inc.	CATHETER, DISP., EXTERNAL, MALE	1977-11-28
K945628	Mentor Corp.	CLEAR ADVANTAGE II	1995-07-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0008-2008	Lemaitre Vascular, Inc.	2	CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Z-0039-05	Medrad Inc	2	Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only

Similar Registrations

Registration Number	Establishment Name	Location
3014167550	GUANGDONG DEXIN SPORTS INDUSTRY CO.,LTD	Guangzhou Guangdong, CN
3011983031	VERMONT MANUFACTURING SERVICES, INC.	West Rutland, VT, US
3016450032	PLANET HOLDINGS LIMITED	Hong Kong, HK
3011066654	SHENZHEN JOOSE BEAUTY ELECTRONIC CO.,LTD	Shen Zhen Guangdong, CN
8043323	FOURSTAR GROUP INC.	TAIPEI, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001650535. Last updated year: 2026. Please use registration number 3001650535 when referencing this establishment in official correspondence.