Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000286794

FEI Number

1000286794

Entity Name

STERLAB

City/State/Country

VALLAURIS Alpes-Maritimes, FR

Establishment Address

2720 CHEMIN SAINT BERNARD, VALLAURIS Alpes-Maritimes 06220, FR

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

STERLAB (Owner Number: 10042816)

Owner / Operator Contact Address

2720 CHEMIN SAINT BERNARD, VALLAURIS, FR-06 06224, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HPZ	Implant, Eye Sphere	Ophthalmic	Class 2	886.3320	2013-11-08
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2017-02-01
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2013-11-08
NGY	Cannula, Trocar, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-11-08
LZU	Plug, Punctum	Unknown	Class U	N/A	2013-11-08
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2013-11-08
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	2014-01-21
HQX	Implant, Orbital, Extra-Ocular	Ophthalmic	Class 2	886.3340	2013-11-08
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2014-01-21
LZU	Plug, Punctum	Unknown	Class U	N/A	2013-11-08
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2013-11-08
KYJ	Prosthesis, Finger, Constrained, Polymer	Orthopedic	Class 2	888.3230	2022-09-28
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-11-08
HJK	Lens, Contact, Polymethylmethacrylate, Diagnostic	Ophthalmic	Class 2	886.1385	2013-11-08
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-11-08
KCW	Epilator, High Frequency, Needle-Type	General, Plastic Surgery	Class 1	878.5350	2014-01-21
EKP	Reamer, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2014-01-21
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2017-02-01

Official Correspondent

Nathalie MATOSSIAN

US Agent Details

Jonathan A. WILDER Business: STERICERT CO. Email: jwilder@stericert.com Phone: (267) 2692779

Related Public Records

Same Entity

STERLAB

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006174295	STERLAB	SIGNES Var, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K811830	Cordis Corp.	C-DAK DUO-FLUX ARTIFICIAL KIDNEY	1981-09-21
K070320	Edwards Lifesciences Services GmbH	EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01	2007-06-07
K150880	Outset Medical	Tablo Console with Wireless Capability	2015-05-01
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2007	Integrated Orbital Implants Inc	2	Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S
Z-0019-2025	Outset Medical, Inc.	2	Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
Z-0028-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis SYS, with CDX
Z-0029-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis System without CDX
Z-0030-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis System w/Bibag

Similar Registrations

Registration Number	Establishment Name	Location
2518410	GULDEN OPHTHALMICS	Elkins Park, PA, US
2245590	Sterigenics U.S., LLC	Salem, NJ, US
2242450	KATENA PRODUCTS, INC.	Randolph, NJ, US
3010162973	Synergy Health Marseille SAS	MARSEILLE CEDEX 14 Provence-Alpes-Cote d'Azur, FR
3002991496	FCI FRANCE CHIRURGIE INSTRUMENTATION	PARIS Ile-de-France, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000286794. Last updated year: 2026. Please use registration number 1000286794 when referencing this establishment in official correspondence.