FDA Registration
Active
🇰🇷 South Korea
SMENG CO.,LTD.
Reg #: 3008912461
·
FEI: 3008912461
·
Expires 2026
Products
14
Proprietary Names
4
Establishment Types
1
Classifications
14
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Registration Details
- Registration Name
- SMENG CO.,LTD.
- Registration Number
- 3008912461
- FEI Number
- 3008912461
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 46, Nakdong-daero 1302beon-gil, Sasang-gu
- City
- Busan
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K161633
Owner / Operator
- Firm Name
- SMENG co.,ltd.
- Operator Number
- 10044758
- Address
- 46,Nakdong-daero 1302beon-gil, Sasang-gu
- City
- Busan
- State
- KR-26
- Postal Code
- 46910
- Country
- KR
- Correspondent
- Gilsoo Lee
US Agent
- Business Name
- Applied Dental, Incorporated
- Contact Name
- Vera Au
- Address
- 1296 Kifer Road, Suite 608,
- City
- Sunnyvale
- State
- CA
- ZIP
- 94086
- Country
- US
- [email protected]
- Phone
- 408 7248832
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2017-03-14 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2017-03-14 |
| Needle, Ophthalmic Suturing | HNM | Class 1 | Ophthalmic | No | 2014-09-02 |
| Needle, Cerclage, Gynecological | HDH | Class 1 | Obstetrics/Gynecology | No | 2014-09-02 |
| Needle, Neurosurgical Suture | HAS | Class 1 | Neurology | No | 2014-09-02 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2017-02-13 |
| Needle, Tonsil Suturing | KBR | Class 1 | Ear, Nose, Throat | No | 2014-09-02 |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | Class 2 | General, Plastic Surgery | No | 2018-07-16 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2014-09-02 |
| Needle, Suturing, Disposable | GAB | Class 1 | General, Plastic Surgery | No | 2014-06-05 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2014-05-14 |
| Needle, Suturing, Reusable | GDL | Class 1 | General, Plastic Surgery | No | 2014-06-05 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2019-01-08 |
| Stapler, Skin | QQS | Class 1 | General Hospital | No | 2022-05-04 |
Proprietary Names
SM ENG CO.,LTD,
Ez-Tcon Mono, Ez-Tcon Needle
Ez-Tcon Surgi, Ez-Tcon Needle
SM ENG CO.,LTD
Establishment Types
Manufacture Medical Device