FDA Registration
Active
🇨🇳 China
Suzhou Meccan Import and Export Corp.
Reg #: 3001650535
·
FEI: 3001650535
·
Expires 2026
Products
70
Proprietary Names
33
Establishment Types
5
Classifications
70
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Registration Details
- Registration Name
- Suzhou Meccan Import and Export Corp.
- Registration Number
- 3001650535
- FEI Number
- 3001650535
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 53 Ruyuan Rd
- City
- Suzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K130231
Owner / Operator
- Firm Name
- SUZHOU MECCAN IMP. & EXP. CORPORATION
- Operator Number
- 9045121
- Address
- 5 FL., ZHUHUI COMMERCIAL BLDG., 180 ZHUHUI ROAD
- City
- SUZHOU, JIANGSU PROVINCE
- State
- CN-NOTA
- Postal Code
- 215006
- Country
- CN
US Agent
- Business Name
- Simcon International LLC
- Contact Name
- Rosanna Lee
- Address
- 1200 Townline Rd
- City
- MUNDELEIN
- State
- IL
- ZIP
- 60060
- Country
- US
- [email protected]
- Phone
- 847 9492290
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Strip, Temperature, Forehead, Liquid Crystal | KPD | Class 2 | General Hospital | No | 2019-03-26 |
| Monitor, Bed Patient | KMI | Class 1 | General Hospital | No | 2004-04-16 |
| Spectacle, Magnifying | HOI | Class 1 | Ophthalmic | No | 2022-09-20 |
| Stimulator, Nerve, Battery-Powered | BXN | Class 2 | Anesthesiology | No | 2013-04-16 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-21 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2004-01-06 |
| Adaptor, Dressing | ILD | Class 1 | Physical Medicine | No | 2015-10-19 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2015-03-25 |
| Cane, Safety Walk | KHY | Class 1 | Physical Medicine | No | 2018-10-31 |
| Strap, Head, Gas Mask | BTK | Class 1 | Anesthesiology | No | 2020-02-21 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2007-05-17 |
| Protector, Dental | BRW | Class 1 | Anesthesiology | No | 2015-10-19 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2002-08-05 |
| Device, Incontinence, Urosheath Type, Sterile | EXJ | Class 1 | Gastroenterology, Urology | No | 2003-04-23 |
| Absorber, Saliva, Paper | KHR | Class 1 | Dental | No | 2017-02-22 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2025-12-05 |
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 2019-06-04 |
| Scissors, Medical, Disposable | JOK | Class 1 | General Hospital | No | 2013-12-05 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2022-09-20 |
| Holder, Ureteral Catheter | EYJ | Class 1 | Gastroenterology, Urology | No | 2014-10-26 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2020-05-06 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2020-05-30 |
| Bag, Bile Collecting | EXF | Class 2 | Gastroenterology, Urology | No | 2020-05-30 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2022-09-09 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2011-07-27 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2010-12-03 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2010-12-03 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2011-07-19 |
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2020-05-30 |
| Exerciser, Non-Measuring | ION | Class 1 | Physical Medicine | No | 2015-12-01 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2020-05-14 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2015-10-27 |
| Stripper, Vein, Disposable | GAJ | Class 1 | General, Plastic Surgery | No | 2013-11-19 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-04-29 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2014-05-29 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2022-09-20 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | Class 1 | Gastroenterology, Urology | No | 2013-03-28 |
| Finger Cot | LZB | Class 1 | General Hospital | No | 2009-12-07 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-04-02 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2007-05-17 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2010-11-19 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2011-07-27 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2005-04-29 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2015-06-29 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2017-01-06 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2014-05-29 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2004-04-08 |
| Needle, Suturing, Disposable | GAB | Class 1 | General, Plastic Surgery | No | 2010-09-27 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2017-02-22 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2005-06-13 |
| Device, Incontinence, Urosheath Type, Non-Sterile | NNX | Class 1 | Gastroenterology, Urology | No | 2016-05-05 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2013-04-25 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2010-11-17 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2010-11-17 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2020-05-06 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2017-02-22 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2012-05-22 |
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2017-04-07 |
| Light, Surgical, Accessories | FTA | Class 2 | General, Plastic Surgery | No | 2011-08-04 |
| Chair, Dental, Without Operative Unit | NRU | Class 1 | Dental | No | 2019-09-16 |
| Flowmeter, Tube, Thorpe, Back-Pressure Compensated | CAX | Class 1 | Anesthesiology | No | 2015-11-17 |
| Pill Crusher/Cutter | OHY | Class 1 | General Hospital | No | 2010-03-25 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2019-05-14 |
| Board, Arm (With Cover), Sterile | BTX | Class 1 | General, Plastic Surgery | No | 2001-03-15 |
| Bottle, Hot/Cold Water | FPF | Class 1 | General Hospital | No | 2006-07-18 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2003-03-03 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2010-11-18 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2015-10-19 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2008-03-18 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2015-10-19 |
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
ANESTHESIA CIRCUIT
Bariatric Tape Measure
Z-Slider
Finger Tip Pulse Oximeter
ARMBOARD
HOT WATER BOTTLE
COLD PACK
Blade Disarmer
Establishment Types
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)