FDA Registration
Active
🇨🇳 China
ONEHALF DESIGN CO.,LTD
Reg #: 3027518263
·
FEI: 3027518263
·
Expires 2026
Products
1
Proprietary Names
8
Establishment Types
2
Classifications
1
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Registration Details
- Registration Name
- ONEHALF DESIGN CO.,LTD
- Registration Number
- 3027518263
- FEI Number
- 3027518263
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 302, Plant 2, No.8 Zidong Avenue, Tianqiao District
- City
- Jinan Shandong
- Country
- CN
Owner / Operator
- Firm Name
- OneHalf Design Co.,LTD
- Operator Number
- 10087960
- Address
- 302, Plant 2, No.8 Zidong Avenue, Tianqiao District
- City
- Jinan
- State
- Shandong
- Postal Code
- 250000
- Country
- CN
- Correspondent
- Luyang Guo
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 |
|---|---|---|---|---|---|
| Attachment, Teaching, For Endoscope | FEA | Class 1 | Gastroenterology, Urology | No | 2023-05-06 |
Proprietary Names
Advanced Abdominal Simulation Trainer Box (Teaching), Abdominal Single-port Trainer Box (Teaching),
3D Suture Module (Teaching), Positioning Skin Module (Teaching), Stripping Module (Teaching),
Foldable Trainer Box (Teaching), Hemispheric Trainer Box (Teaching),
Endoscopic Fenestrated Grasper (Teaching), Endoscopic Scissor (Teaching)
Banding Training Module (Teaching), Trocar (Teaching), Straight Rod Endoscope (Teaching),
Perforation Module (Teaching), Intestinal Module (Teaching), Clip Module (Teaching), Clamping Module (Teaching),
Precision Cutting Module (Teaching)
Endoscopic Needle Holder (Teaching), Endoscopic Dissecting Forceps (Teaching),
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device