FDA Registration
Active
🇰🇷 South Korea
SHINA CORP.
Reg #: 8040619
·
FEI: 3002808190
·
Expires 2026
Products
5
Proprietary Names
21
Establishment Types
4
Classifications
5
Registration Details
- Registration Name
- SHINA CORP.
- Registration Number
- 8040619
- FEI Number
- 3002808190
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8-26, BOJEOKDONG-GIL, USEONG-MYEON,
- City
- GONGJU-SI Chungnam
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K103011
Owner / Operator
- Firm Name
- SHINA CORP.
- Operator Number
- 8040619
- Address
- # 1005, 28, HWANGSAEUL-RO, 200 BEON-GIL, BUNDANG-GU
- City
- SEONGNAM-SI
- State
- Gyeonggi
- Postal Code
- 13595
- Country
- KR
- Correspondent
- Y. C BANG
US Agent
- Business Name
- LK Consulting Group USA, Inc.
- Contact Name
- PRISCILLA CHUNG
- Address
- 2552 Walnut Ave Ste 230
- City
- Tustin
- State
- CA
- ZIP
- 92780
- Country
- US
- [email protected]
- Phone
- 714 9225276
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2011-12-19 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2011-12-19 |
| Syringe, Antistick | MEG | Class 2 | General Hospital | No | 2011-12-19 |
| Endoilluminator | MPA | Class 2 | Gastroenterology, Urology | No | 2026-04-27 |
| Container, Sharps | MMK | Class 2 | General Hospital | No | 2020-03-31 |
Proprietary Names
UltiCare Insulin Safety Syringes
Assure ID Insulin Safety Syringes
Exel Disposable Syringes
Ulticare
SureComfort insulin pen needles
Premier
CareOne
inControl
ShinaPen
Shina Safety Needle
Nam illumination probe with chopper
ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE
SHINA
SureComfort insulin syringes
Shina
PISTON SYRINGE
S'CARE
ULTI GUARD HOME INSULIN SYRINGE CONTAINER
ULTICARE
Sure-Fine Insulin Syringes
Vacu-Med
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Sterilize Medical Device for Another Party (Contract Sterilizer)