FDA Registration
Active
🇨🇳 China
MERITS HEALTHCARE INDUSTRIES. (SUZHOU) CO., LTD.
Reg #: 9618009
·
FEI: 3003327839
·
Expires 2026
Products
31
Proprietary Names
87
Establishment Types
3
Classifications
31
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Registration Details
- Registration Name
- MERITS HEALTHCARE INDUSTRIES. (SUZHOU) CO., LTD.
- Registration Number
- 9618009
- FEI Number
- 3003327839
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO. 29 FUZHOU ROAD, TAICANG CITY
- City
- JIANGSU PROVINCE
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K933406
Owner / Operator
- Firm Name
- MERITS HEALTHCARE INDUSTRIES. (SUZHOU) CO., LTD.
- Operator Number
- 9045042
- Address
- NO. 29 FUZHOU ROAD, TAICANG CITY
- City
- JIANGSU PROVINCE
- State
- CN-JS
- Postal Code
- 215411
- Country
- CN
US Agent
- Business Name
- mdi Consultants, Inc.
- Contact Name
- Alan Schwartz
- Address
- 55 Northern Blvd
- City
- Great Neck
- State
- NY
- ZIP
- 11021
- Country
- US
- [email protected]
- Phone
- 516 4829001
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Components, Wheelchair | KNN | Class 1 | Physical Medicine | No | 2011-06-01 |
| Belt, Wheelchair | IQB | Class 1 | Physical Medicine | No | 2012-09-07 |
| Exerciser, Non-Measuring | ION | Class 1 | Physical Medicine | No | 2011-06-01 |
| Accessories, Wheelchair | KNO | Class 1 | Physical Medicine | No | 2010-10-15 |
| Board, Scooter, Prone | KNL | Class 1 | Physical Medicine | No | 2012-09-07 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2011-08-10 |
| Holder, Crutch And Cane, Wheelchair | IMZ | Class 1 | Physical Medicine | No | 2012-09-07 |
| Restraint, Wheelchair, Non-Protective | KID | Class 1 | Physical Medicine | No | 2012-09-07 |
| Attachment, Commode, Wheelchair | INB | Class 1 | Physical Medicine | No | 2011-06-01 |
| Bariatric Bed | OSI | Class 2 | General Hospital | No | 2016-03-22 |
| Chair, Adjustable, Mechanical | INN | Class 1 | Physical Medicine | No | 2012-09-07 |
| Wheelchair, Mechanical | IOR | Class 1 | Physical Medicine | No | 2008-03-19 |
| Climber, Curb, Wheelchair | IMN | Class 1 | Physical Medicine | No | 2012-09-07 |
| Cuff, Pusher, Wheelchair | INC | Class 1 | Physical Medicine | No | 2012-09-07 |
| Crutch | IPR | Class 1 | Physical Medicine | No | 2011-06-07 |
| Chair And Table, Medical | KMN | Class 1 | General Hospital | No | 2011-06-01 |
| Wheelchair, Powered | ITI | Class 2 | Physical Medicine | No | 2012-09-28 |
| Cushion, Wheelchair | IMP | Class 1 | Physical Medicine | No | 2011-12-16 |
| Device, Anti-Tip, Wheelchair | IMR | Class 1 | Physical Medicine | No | 2012-09-07 |
| Armboard, Wheelchair | IMY | Class 1 | Physical Medicine | No | 2012-09-07 |
| Armrest, Wheelchair | IML | Class 1 | Physical Medicine | No | 2012-09-07 |
| Board, Lap, Wheelchair | IMX | Class 1 | Physical Medicine | No | 2012-09-07 |
| Support, Head And Trunk, Wheelchair | IMS | Class 1 | Physical Medicine | No | 2012-09-07 |
| Bed, Manual | FNJ | Class 1 | General Hospital | No | 2010-03-02 |
| Handrim, Wheelchair | IMO | Class 1 | Physical Medicine | No | 2012-09-07 |
| Hill Holder, Wheelchair | INA | Class 1 | Physical Medicine | No | 2012-09-07 |
| Bed, Ac-Powered Adjustable Hospital | FNL | Class 2 | General Hospital | No | 2011-05-26 |
| Vehicle, Motorized 3-Wheeled | INI | Class 2 | Physical Medicine | No | 2012-05-01 |
| Brake, Extension, Wheelchair | IMW | Class 1 | Physical Medicine | No | 2012-09-07 |
| Chair, With Casters | INM | Class 1 | Physical Medicine | No | 2012-09-07 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2011-06-01 |
Proprietary Names
MANUAL WHEELCHAIR COMPONENTS
BELT, WHEELCHAIR
PEDAL EXERCISER
manual wheel chair accessories
BOARD, SCOOTER, PRONE
STAND, INFUSION
HOLDER, CRUTCH AND CANE, WHEELCHAIR
RESTRAINT, WHEELCHAIR, NON-PROTECTIVE
C313
D101
C315
C401
C316
C321
C314
C317
C311
C312
3999AM84
CHAIR, ADJUSTABLE, MECHANICAL
N473
N421
N472
N700
N211
L223
N480
L247
N451
L405
N2469
N424
L248
L222
CLIMBER, CURB, WHEELCHAIR
CUFF, PUSHER, WHEELCHAIR
FOREARM CRUTCH
CRUTCH
UNDERARM CRUTCH
OVER BED TABLE
P326A
P326E
P326D
CUSHION
MERITS MODEL P322FWD POWERED WHEELCHAIR
P322A
P322B
P322
DEVICE, ANTI-TIP, WHEELCHAIR
ARMBOARD, WHEELCHAIR
ARMREST, WHEELCHAIR
BOARD, LAP, WHEELCHAIR
SUPPORT, HEAD AND TRUNK, WHEELCHAIR
B010
R2021
R211
R210
HANDRIM, WHEELCHAIR
HILLHOLDER, WHEELCHAIR
B320
B3112
B310
B211
B311
B330
B210
S731
S730
S237
BRAKE, EXTENSION, WHEELCHAIR
S247
S740
S741
L819
CHAIR, WITH CASTERS
P181
P183
P101
P182
TOILET SAFETY FRAME
SHOWER SPRAY
FOOT STOOL
GRAB BAR
RAISED TOILET SEAT
TRANSFER BENCH
BATH BENCH
TUB RAIL
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)