FDA Registration
Active
🇲🇨 Monaco
PROMEPLA S.A.M
Reg #: 3006617533
·
FEI: 3006617533
·
Expires 2026
Products
12
Proprietary Names
23
Establishment Types
4
Classifications
12
Registration Details
- Registration Name
- PROMEPLA S.A.M
- Registration Number
- 3006617533
- FEI Number
- 3006617533
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9 AVENUE PRINCE ALBERT II
- City
- MONACO Monaco-Ville
- Country
- MC
Owner / Operator
- Firm Name
- PROMEPLA
- Operator Number
- 9092365
- Address
- 9 AVENUE ALBERT II, --
- City
- MONACO
- State
- Monaco-Ville
- Postal Code
- 98000
- Country
- MC
- Correspondent
- kim HERBERT
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lithotriptor, Electro-Hydraulic | FFK | Class 2 | Gastroenterology, Urology | No | 2023-04-26 |
| Lithotriptor, Ultrasonic | FEO | Class 2 | Gastroenterology, Urology | No | 2023-04-26 |
| Injector, Contrast Medium, Automatic | IZQ | Class 2 | Cardiovascular | No | 2026-01-21 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2026-01-08 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2007-08-01 |
| Microtools, Assisted Reproduction (Pipettes), Exempt | PUC | Class 2 | Obstetrics/Gynecology | No | 2024-10-24 |
| Tube, Smoke Removal, Endoscopic | FCZ | Class 1 | Gastroenterology, Urology | No | 2011-01-25 |
| Dislodger, Stone, Flexible | FGO | Class 2 | Gastroenterology, Urology | No | 2023-04-26 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2013-01-17 |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | Class 2 | General, Plastic Surgery | No | 2026-03-18 |
| Needle, Catheter | GCB | Class 1 | General, Plastic Surgery | No | 2024-10-31 |
| Device, Cystometric, Hydraulic | FEN | Class 2 | Gastroenterology, Urology | No | 2012-09-24 |
Proprietary Names
Swiss LithoClast® Trilogy
ulrichINJECT CT motion
tubing set
Tubing, with filter, sterile, for insufflation
Hunter Scientific Pasteur Pipette PPB150-100; Hunter Scientific Pasteur Pipette PPB150-100PL; Hunter Scientific Pasteur
ulricheasyINJECT
Tubing, sterile, for UIII smoke evaluation
Stone catcher with tubing and adapter
Stone Catcher for Swiss LithoClast® Trilogy
ulricheasyINJECT Max
Catheter for irrigation, irrigation line
Endoscopic irrigation line TraxerFlow, double spikes, with flushing pump, universal connector and Tuohy-Borst
Irrigation Tube
Irrigation Chiropro L3.5m
Y-Connector
Irrigation line KM
Irrigation lines
MORPHEUS PUMP TUBE SET
Surgical irrigation tube
soring inc
Russell PneumoFix-8 PDF119
Russell PneumoFix PDF112
CT3000 Pro, UroCuff
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility