FDA Registration
Active
🇨🇭 Switzerland
APPLIMED SA -CSSR
Reg #: 3010163695
·
FEI: 3010163695
·
Expires 2026
Products
41
Proprietary Names
38
Establishment Types
1
Classifications
41
Registration Details
- Registration Name
- APPLIMED SA -CSSR
- Registration Number
- 3010163695
- FEI Number
- 3010163695
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Route de Pra de Plan 3
- City
- Châtel St Denis Fribourg
- Country
- CH
Owner / Operator
- Firm Name
- Applimed SA
- Operator Number
- 10042371
- Address
- Route de Pra de Plan 1
- City
- Châtel St Denis
- State
- Fribourg
- Postal Code
- 1618
- Country
- CH
- Correspondent
- Sasan Danechi
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2021-12-07 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2026-02-23 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2019-07-30 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2026-02-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2019-07-30 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2023-01-11 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2020-12-17 |
| Right Ventricular Bypass (Assist) Device | OJE | Class f | Unknown | No | 2024-01-23 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2019-07-30 |
| Motor, Drill, Electric | HBC | Class 2 | Neurology | No | 2026-02-19 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2026-02-19 |
| Microdebrider, Ent, High Speed, Single Use, Reprocessed | NLY | Class 1 | Ear, Nose, Throat | No | 2026-02-19 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2026-02-19 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2019-07-30 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2025-03-13 |
| Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | KFM | Class 2 | Cardiovascular | No | 2013-01-09 |
| Blood Pump For Ecmo, Long-Term (> 6 Hours) Use | QNR | Class 2 | Cardiovascular | No | 2024-01-23 |
| Ventricular (Assist) Bypass | DSQ | Class 3 | Unknown | No | 2024-01-23 |
| Orthopedic Augmented Reality | SBF | Class 2 | Neurology | No | 2021-12-07 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2026-02-23 |
| Blade, Saw, Surgical, Cardiovascular | DWH | Class 1 | General, Plastic Surgery | No | 2026-02-19 |
| System, Perfusion, Kidney | KDN | Class 2 | Gastroenterology, Urology | No | 2022-01-26 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2019-07-30 |
| Radiation Therapy Marking Device | QRN | Class 2 | Radiology | No | 2022-03-03 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2020-12-17 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2019-07-30 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2019-07-30 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2019-07-30 |
| Prosthesis, Hip, Cement Restrictor | JDK | Class 2 | General, Plastic Surgery | No | 2021-12-07 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2021-12-07 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2021-12-07 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2026-02-23 |
| Guide, Wire, Catheter, Neurovasculature | MOF | Class 2 | Cardiovascular | No | 2024-06-12 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2024-06-12 |
| Console, Heart-Lung Machine, Cardiopulmonary Bypass | DTQ | Class 2 | Cardiovascular | No | 2024-01-23 |
| Heat-Exchanger, Cardiopulmonary Bypass | DTR | Class 2 | Cardiovascular | No | 2024-01-23 |
| Oxygenator, Cardiopulmonary Bypass | DTZ | Class 2 | Cardiovascular | No | 2024-01-23 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2024-01-23 |
| Control, Pump Speed, Cardiopulmonary Bypass | DWA | Class 2 | Cardiovascular | No | 2024-01-23 |
| Accessory Equipment, Cardiopulmonary Bypass | KRI | Class 1 | Cardiovascular | No | 2024-01-23 |
| Orthopaedic Surgical Planning And Instrument Guides | PBF | Class 2 | Orthopedic | No | 2024-01-23 |
Proprietary Names
MectaLock All Suture
Medacta International
Bien-Air Surgery
MOTO Partial Knee & MOTO PFJ Systems Extension
OR30 TM
TANDEM INTL BIPOLAR
CentriMag Right Ventricular Assist System (RVAS, HDE)
MPACT Extension
Mpact
MectaFix CL
MectaLock TI Triple Loaded Suture Anchor
Mbrace System
CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System
CentriMag Circulatory Support System
MectaLockk PEEK Suture Anchor
Next AR
Next AR Externsion
FairFix Adjustable Button
SnugFit All-Suture Anchor
MectaTap TI Suture Anchor
Fairfix QT Adjustable button
NextAR TM RSA Platform
GMK Revision & Hinge Extension - TiNbN Coating
MectaLock Ti Suture Anchor
KIDNEY ASSIT-transport
GMK-Sphere E-Cross inserts and patellae
Genesis II Knee System
POLARCUP TM
Fairfix AM & PSP Adjustable Buttons
Comfort Market 2
BIRMINGHAM HIP
MectaPlug PE II
MOTO PFJ (Only Moto Patella)
SmartGUIDE deflectable hydrophilic guidewire
CentriMag Pre-connected Pack
MectaLock Suture Anchor Extension
MOTO Lateral Knee System
NextAR TM Spine Platform
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)