FDA Registration
Active
🇩🇴 Dominican Republic
CEA Global Dominicana d.b.a. Nissha Medical Technologies
Reg #: 3006891611
·
FEI: 3006891611
·
Expires 2026
Products
13
Proprietary Names
4
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- CEA Global Dominicana d.b.a. Nissha Medical Technologies
- Registration Number
- 3006891611
- FEI Number
- 3006891611
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Zona Franca Industrial
- City
- San Pedro de Macoris
- Country
- DO
Owner / Operator
- Firm Name
- Nissha Medical Technologies
- Operator Number
- 10023988
- Address
- 400 Exchange Street
- City
- Buffalo
- State
- NY
- Postal Code
- 14204
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2021-10-27 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2022-09-30 |
| Cardiac Ablation Percutaneous Catheter | LPB | Class 3 | Unknown | No | 2015-05-22 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2014-12-12 |
| Septal Stapler/Absorbable Staples | OLL | Class 2 | General, Plastic Surgery | No | 2020-09-16 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2022-06-06 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2023-02-02 |
| Endoscopic Irrigation/Suction System | OCX | Class 2 | Gastroenterology, Urology | No | 2024-06-24 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2022-06-06 |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | Class 2 | Cardiovascular | No | 2019-05-09 |
| Catheter, Straight | EZD | Class 2 | Gastroenterology, Urology | No | 2025-04-23 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | Class 3 | Unknown | No | 2023-12-14 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2023-02-02 |
Proprietary Names
BodyGuardian Mini Strip; BodyGuardian Strip
Electrical Umbilical 2035U Electrical Umbilical 2035UC
DIEGO TUBE SET (6/PK)
Attain Hybrid Guide Wire
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)