FDA Registration
Active
🇫🇷 France
STERLAB
Reg #: 3006174295
·
FEI: 3006174295
·
Expires 2026
Products
26
Proprietary Names
54
Establishment Types
1
Classifications
26
Registration Details
- Registration Name
- STERLAB
- Registration Number
- 3006174295
- FEI Number
- 3006174295
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 485 avenue de berlin, Parc d'activites du Plateau de Signes
- City
- SIGNES Var
- Country
- FR
Owner / Operator
- Firm Name
- STERLAB
- Operator Number
- 10042816
- Address
- 2720 CHEMIN SAINT BERNARD
- City
- VALLAURIS
- State
- Alpes-Maritimes
- Postal Code
- 06224
- Country
- FR
- Correspondent
- Nathalie MATOSSIAN
US Agent
- Business Name
- STERICERT CO.
- Contact Name
- Jonathan A. WILDER
- Address
- 600 Bethlehem Pike
- City
- Erdenheim
- State
- PA
- ZIP
- 19038
- Country
- US
- [email protected]
- Phone
- 267 2692779
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Injector, Contrast Medium, Automatic | IZQ | Class 2 | Cardiovascular | No | 2026-01-26 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2023-01-09 |
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2013-02-04 |
| Accessories, Catheter, G-U | KNY | Class 2 | Gastroenterology, Urology | No | 2013-02-04 |
| Stylet, Ureteral | EYA | Class 1 | Gastroenterology, Urology | No | 2013-01-25 |
| Device, Cystometric, Hydraulic | FEN | Class 2 | Gastroenterology, Urology | No | 2013-01-25 |
| Evacuator, Gastro-Urology | KQT | Class 2 | Gastroenterology, Urology | No | 2013-02-04 |
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | Class 2 | Gastroenterology, Urology | No | 2018-06-07 |
| Apparatus, Hemoperfusion, Sorbent | FLD | Class 2 | Gastroenterology, Urology | No | 2018-06-07 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2013-02-04 |
| Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma | MDP | Class 3 | Unknown | No | 2026-05-05 |
| Surgical Film | OOD | Class 2 | General, Plastic Surgery | No | 2024-02-14 |
| Mesh, Surgical, Absorbable, Abdominal Hernia | OWT | Class 2 | General, Plastic Surgery | No | 2024-02-14 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2013-01-25 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2020-12-11 |
| Device, Irrigation, Ocular Surgery | KYG | Class 1 | Ophthalmic | No | 2013-02-04 |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | Class 2 | General, Plastic Surgery | No | 2026-03-19 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2013-02-04 |
| Active Implantable Bone Conduction Hearing System | PFO | Class 2 | Ear, Nose, Throat | No | 2025-12-08 |
| Unit, Oral Irrigation | EFS | Class 1 | Dental | No | 2013-02-04 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2014-01-21 |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | Class 2 | Gastroenterology, Urology | No | 2013-01-25 |
| Tube, Smoke Removal, Endoscopic | FCZ | Class 1 | Gastroenterology, Urology | No | 2013-01-25 |
| Epilator, High Frequency, Needle-Type | KCW | Class 1 | General, Plastic Surgery | No | 2014-01-21 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2013-02-04 |
| Reamer, Pulp Canal, Endodontic | EKP | Class 1 | Dental | No | 2014-01-21 |
Proprietary Names
ulrichINJECT CT motion
Parietene Macroporous Mesh
ROCAMED RocaWire Guidewires
MEDIPLUS Urodynamics Sterile
Accessories for Evacuator
Progrip self-gripping polypropylene mesh
Parietene DS Composite Mesh
Prismaflex MARS
Tubing with filter for laparoscopy
Parietene Macroporous Mesh
ProGrip Self-Gripping Polypropylene Mesh
PRISMAFLEX TPE 2000 SET
Transorb Self-gripping resorbable mesh
Catheter Accessories
ProgripTM Self-gripping Polyester Mesh
Broncoflex Agile
Broncoflex Vortex
Various models of ophth
Accessories for intravascular administration sets
Prismaflex HF1000 set
Prismaflex HF1400 set
parietex Composite ventral patch
Sentio Ti Implant Kit
Prismaflex ST set (ST60/ST100/ST150)
Accessories for oral irrigation, various tubes
ONE G
ONE FLARE
2 SHAPE Procedure pack
2 SHAPE
ONE CURVE PROCEDURE PACK
MICROMEGA REMOVER
ONE CURVE
HYFLEX REMOVER
Micromega One Reci (sterile)
Micromega Reci Gilder (sterile)
Micromega One Reci Procedure pack (sterile)
Micromega One Curve Mini procedure pack (sterile)
Micromega One curve Mini (sterile)
MM TAPER
Micromega One Gilder (sterile)
2Shape Mini
ulricheasyINJECT Max
ProGrip advanced self-gripping polypropylene mesh
PRISMAFLEX M150
Progrip Laparoscopic Self-fixating Mesh
ROCAMED RocaStone Extractors
Endoscopy insufflation tubing set
BALLET NEEDLE (L, K, F, ..)
Progrip Laparoscopic Self-Fixating Mesh
Parietene Flat Sheet Mesh
PRISMAFLEX M100
PRISMAFLEX M60
Catheter for irrigation, irrigation line
K-REAMERS
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)