FDA Registration
Active
🇨🇳 China
ZHEJIANG KELONGWEI MEDICAL EQUIPMENT CO., LTD.
Reg #: 3010964789
·
FEI: 3010964789
·
Expires 2026
Products
10
Proprietary Names
18
Establishment Types
2
Classifications
10
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Registration Details
- Registration Name
- ZHEJIANG KELONGWEI MEDICAL EQUIPMENT CO., LTD.
- Registration Number
- 3010964789
- FEI Number
- 3010964789
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Hangzhou Bay Shangyu Economic and Technological Development Area
- City
- Shaoxing Zhejiang
- Country
- CN
Owner / Operator
- Firm Name
- ZHEJIANG KELONGWEI MEDICAL EQUIPMENT CO., LTD.
- Operator Number
- 10046911
- Address
- Hangzhou Bay Shangyu Economic and Technological Development Area
- City
- Shaoxing
- State
- Zhejiang
- Postal Code
- 312300
- Country
- CN
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pill Crusher/Cutter | OHY | Class 1 | General Hospital | No | 2019-04-04 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2020-04-08 |
| Bedpan | FOB | Class 1 | General Hospital | No | 2018-11-19 |
| Urinal | FNP | Class 1 | General Hospital | No | 2018-04-09 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2014-05-29 |
| Dispenser, Solid Medication | NXB | Class 1 | Physical Medicine | No | 2019-09-10 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2020-08-05 |
| Chair, Adjustable, Mechanical | INN | Class 1 | Physical Medicine | No | 2014-05-29 |
| Chair, Geriatric | FRJ | Class 1 | General Hospital | No | 2014-05-29 |
| Bath, Sitz, Nonpowered | KTC | Class 1 | Physical Medicine | No | 2018-11-19 |
Proprietary Names
Pill Cutters/Crushers
GRAB BAR
Bed Pan
Urinal
E-Z Bath and shower seat with handle
Portable Shower Bench
Raised Toilet Seat
Uplift Commode Assist
Commode Assist
Folding Three-in-One Commode
DESKTOP PILL ORGANIZER
AM/PM WEEKLY PILL BOX
Oral Syringe
Upeasy Power Seat
Uplift Power Seats
Upeasy Seat Assist
Uplift Seat Assists
Sitz Bath
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)