FDA Registration
Active
🇲🇾 Malaysia
GREATCARE 4U SDN BHD
Reg #: 3038285060
·
FEI: 3038285060
·
Expires 2026
Products
13
Proprietary Names
12
Establishment Types
2
Classifications
13
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Registration Details
- Registration Name
- GREATCARE 4U SDN BHD
- Registration Number
- 3038285060
- FEI Number
- 3038285060
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No15, Jalan Bestari 1/ku7, Taman Perindustrian Kapar Bestari, Kapar
- City
- Selangor Darul Ehsan
- Country
- MY
Owner / Operator
- Firm Name
- Greatcare 4u sdn bhd
- Operator Number
- 10093267
- Address
- No15, Jalan Bestari 1/ku7, Taman Perindustrian Kapar Bestari, Kapar
- City
- Selangor Darul Ehsan
- State
- MY-NOTA
- Postal Code
- 42200
- Country
- MY
- Correspondent
- Yinbo Xu
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Chair, Dental, Without Operative Unit | NRU | Class 1 | Dental | No | 2025-05-22 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2025-04-21 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2025-04-21 |
| Absorber, Saliva, Paper | KHR | Class 1 | Dental | No | 2025-04-21 |
| Mouthpiece, Saliva Ejector | DYN | Class 1 | Dental | No | 2025-04-21 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2025-04-21 |
| Cover, Mattress (Medical Purposes) | FMW | Class 1 | General Hospital | No | 2025-04-21 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2025-04-21 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2025-04-21 |
| Speculum, Vaginal, Nonmetal | HIB | Class 2 | Obstetrics/Gynecology | No | 2025-04-21 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2025-04-21 |
| Syringe, Irrigating (Dental) | EIB | Class 1 | Dental | No | 2025-04-21 |
| Applicator, Resin | KXR | Class 1 | Dental | No | 2025-04-21 |
Proprietary Names
HEADREST COVER
Disposable curved tip syringe, Disposable flow tip (pre-bent multipurpose dispensing tip)
Disposable Irrigation Syringe
Dental bibs
Disposable saliva ejector
Adult Diaper, Adult pants/pull-ups
Couch paper roll
Wet wipes
Headrest cover
Vaginal Speculum
Disposable endo irrigation needles
Disposable micro applicators
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device