FDA Registration
Active
🇫🇷 France
STERLAB
Reg #: 1000286794
·
FEI: 1000286794
·
Expires 2026
Products
15
Proprietary Names
41
Establishment Types
1
Classifications
15
Registration Details
- Registration Name
- STERLAB
- Registration Number
- 1000286794
- FEI Number
- 1000286794
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2720 CHEMIN SAINT BERNARD
- City
- VALLAURIS Alpes-Maritimes
- 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 |
|---|---|---|---|---|---|
| Implant, Eye Sphere | HPZ | Class 2 | Ophthalmic | No | 2013-11-08 |
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | Class 2 | Gastroenterology, Urology | No | 2017-02-01 |
| Lacrimal Stents And Intubation Sets | OKS | Class U | Unknown | No | 2013-11-08 |
| Cannula, Trocar, Ophthalmic | NGY | Class 1 | Ophthalmic | No | 2013-11-08 |
| Plug, Punctum | LZU | Class U | Unknown | No | 2013-11-08 |
| Spreader, Pulp Canal Filling Material, Endodontic | EKK | Class 1 | Dental | No | 2014-01-21 |
| Implant, Orbital, Extra-Ocular | HQX | Class 2 | Ophthalmic | No | 2013-11-08 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2014-01-21 |
| Prosthesis, Finger, Constrained, Polymer | KYJ | Class 2 | Orthopedic | No | 2022-09-28 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2013-11-08 |
| Lens, Contact, Polymethylmethacrylate, Diagnostic | HJK | Class 2 | Ophthalmic | No | 2013-11-08 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2013-11-08 |
| Epilator, High Frequency, Needle-Type | KCW | Class 1 | General, Plastic Surgery | No | 2014-01-21 |
| Reamer, Pulp Canal, Endodontic | EKP | Class 1 | Dental | No | 2014-01-21 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2026-05-27 |
Proprietary Names
BIOCERAMIC ORBITAL IMPLANT - Box of 1
PRISMAFLEX M150
MASTERKA (DESIGNER B. FAYET, M.D.) - Box of 1
RETILOCK Self-retaining Trocar - Box of 5
SELF-THREADING MONOKA FAYET, BERNARD, RITLENG
SELF-RETAINING BICANALICULUS STENT WITH DISPOSABLE DILATOR - Box of 1
FINGER SPREADER
ePTFE BAND
ePTFE STRIP
ePTFE SPONGE
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
SNUG PLUG - Box of 2
CRAWFORD BICANALICULUS INTUBATION - Box of 3
KeriFlex MCP and PIP Joint Prostheses
SELF-BLOCKING VITRECTOMY INFUSION AND CANNULA SET
DISPOSABLE VITRECTOMY LENS
DISPOSABLE LENS -Box of 5
DISPOSABLE VITRECTOMY SET
BALLET NEEDLE (L, K, F, ..)
K-REAMERS
PRISMAFLEX M100
PRISMAFLEX M60
RITLENG BICANALICULUS INTUBATION
MONO-CRAWFORD B. FAYET, MD
TRAX CR Fixed Bearing Insert
Resurfacing patellar implant NM AXPE Cemented
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)