FDA Registration
Active
🇹🇼 Taiwan
NORTH EOS INDUSTRIES, INC.
Reg #: 8043235
·
FEI: 2981
·
Expires 2026
Products
22
Proprietary Names
26
Establishment Types
1
Classifications
22
Registration Details
- Registration Name
- NORTH EOS INDUSTRIES, INC.
- Registration Number
- 8043235
- FEI Number
- 2981
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO. 46, ZHONGTAI STREET, TUNG-SHIH DISTRICT
- City
- TAICHUNG CITY
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K963685
Owner / Operator
- Firm Name
- NORTH EOS INDUSTRIES, INC.
- Operator Number
- 8043235
- Address
- 46, ZHONG TAI STREET, TUNG-SHIH DISTRICT
- City
- TAICHUNG CITY
- State
- TW-NOTA
- Postal Code
- 423
- Country
- TW
- Correspondent
- TSAI - YIH-CHIOU
US Agent
- Business Name
- i-SMART Consulting US LLC
- Contact Name
- Steven Baker
- Address
- 3495 West Kamran Ridge Cove
- City
- South Jordan
- State
- UT
- ZIP
- 84095
- Country
- US
- [email protected]
- Phone
- 267 4321045
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 1994-01-11 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2006-11-28 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2000-09-07 |
| Transilluminator, Battery-Powered | HJN | Class 1 | Ophthalmic | No | 2018-08-12 |
| Dilator, Cervical, Fixed Size | HDQ | Class 1 | Obstetrics/Gynecology | No | 2004-12-21 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2018-04-30 |
| Dilator, Nasal | LWF | Class 1 | Ear, Nose, Throat | No | 2004-11-15 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 2006-11-16 |
| Stethoscope, Fetal | HGN | Class 1 | Obstetrics/Gynecology | No | 2018-08-12 |
| Spatula, Cervical, Cytological | HHT | Class 2 | Obstetrics/Gynecology | No | 2008-01-18 |
| Cleanser, Denture, Over The Counter | EFT | Class 1 | Dental | No | 2001-03-12 |
| Speculum, Rectal | FFQ | Class 1 | Gastroenterology, Urology | No | 2018-01-13 |
| Illuminator, Color Vision Plate | HJD | Class 1 | Ophthalmic | No | 2017-12-27 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2018-01-25 |
| Endoscope, Ac-Powered And Accessories | GCP | Class 2 | Gastroenterology, Urology | No | 2008-01-18 |
| Expander, Surgical, Skin Graft | FZW | Class 1 | General, Plastic Surgery | No | 1993-11-10 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2018-08-12 |
| Speculum, Vaginal, Nonmetal | HIB | Class 2 | Obstetrics/Gynecology | No | 2005-12-16 |
| Remover, Intrauterine Device, Contraceptive, Hook-Type | HHF | Class 1 | Obstetrics/Gynecology | No | 2008-09-12 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2006-11-16 |
| Sound, Uterine | HHM | Class 1 | Obstetrics/Gynecology | No | 2004-09-22 |
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 2005-09-06 |
Proprietary Names
Eyelid Speculum
EOS EyelidSpec
EOS BRAND DISPOSABLE
EOSOTOSPEC
EOS BRAND SUCTION
EosChamber II -light
uterine dilator
EOS BRAND
DentSpec
NasalSpec
EOSCURETTE
EosStethoscope
EosBrush, EosSmear
DentBox
ProctoSpec
EOSLED
EosBeauty Tray
Proctoscope
EOS BRAND DISPOSABLE ORAL EXPANDER
EosProbe
EOSSPEC
EosSaver
EOS brand IUD saver
EOS BEAUTY TRAY
EOSSOUNDS
EosTips
Establishment Types
Manufacture Medical Device