FDA Registration
Active
🇨🇭 Switzerland
NOUVAG AG
Reg #: 9680741
·
FEI: 3005601686
·
Expires 2026
Products
17
Proprietary Names
38
Establishment Types
4
Classifications
17
Registration Details
- Registration Name
- NOUVAG AG
- Registration Number
- 9680741
- FEI Number
- 3005601686
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ST. GALLERSTRASSE 25
- City
- GOLDACH Sankt Gallen
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K042943
Owner / Operator
- Firm Name
- NOUVAG AG
- Operator Number
- 9008454
- Address
- ST. GALLERSTRASSE 25, --
- City
- GOLDACH
- State
- Sankt Gallen
- Postal Code
- 9403
- Country
- CH
US Agent
- Business Name
- Ken Block Consulting LLC
- Contact Name
- Kenneth Block
- Address
- 3400 N Central Expy Ste 100265
- City
- Richardson
- State
- TX
- ZIP
- 75080
- Country
- US
- [email protected]
- Phone
- 972 4809554
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2020-09-04 |
| Expander, Surgical, Skin Graft | FZW | Class 1 | General, Plastic Surgery | No | 2015-09-07 |
| Dermatome | GFD | Class 1 | General, Plastic Surgery | No | 2010-01-29 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2016-07-21 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2017-02-20 |
| Saw, Powered, And Accessories | HAB | Class 1 | General, Plastic Surgery | No | 2010-01-29 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2018-08-10 |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | Class 2 | General, Plastic Surgery | No | 2007-10-29 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2004-08-12 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2019-07-02 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2007-10-30 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2007-10-29 |
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2007-10-29 |
| Motor, Drill, Electric | HBC | Class 2 | Neurology | No | 2007-10-29 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2017-09-14 |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | Class 1 | Dental | No | 2007-10-29 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | Class 1 | Anesthesiology | No | 2019-11-27 |
Proprietary Names
Ultraneb
Meshgraft Tissue Expansion System
Meshboard
Blades for dermatome and mucotome
Dermatome
Mucotome
HighSurg 30
HighTorQ
HighSurg 11
Infiltration Tubing Set
Tubing Set
Irrigation Tubing Set
Saw blades
MSS 5000 Micro compass saw
OMS 5000 Micro oscillating saw
MOS 5000 Sagittal micro saw
Suction tube
Vacuson 40
Vacuson 60
Spinal Burr handpiece 1910
Burr, drill general surgery
Spinal burr
TCM 3000 BL
Clip for external cooling
CHP Handpiece
Craniotom drill
Dispenser DP 30
Dispenser DP 30 LipoPlus
LipoSurg
MD 11
Handpieces ENT
MD 30
Liposuction cannula
Y-Connector
Handpiece
Clip for internal cooling
Contra angle
Vexio cart
Establishment Types
Foreign Private Label Distributor
Manufacture Medical Device
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device