Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006174295

FEI Number

3006174295

Entity Name

STERLAB

City/State/Country

SIGNES Var, FR

Establishment Address

485 avenue de berlin, Parc d'activites du Plateau de Signes, SIGNES Var 83870, 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

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 ulrichINJECT CT motion Broncoflex Vortex Broncoflex Agile 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 ulricheasyINJECT Max PRISMAFLEX M150

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2026-01-26
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2023-01-09
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2013-02-04
KNY	Accessories, Catheter, G-U	Gastroenterology, Urology	Class 2	876.5130	2013-02-04
EYA	Stylet, Ureteral	Gastroenterology, Urology	Class 1	876.5130	2013-01-25
FEN	Device, Cystometric, Hydraulic	Gastroenterology, Urology	Class 2	876.1620	2013-01-25
KQT	Evacuator, Gastro-Urology	Gastroenterology, Urology	Class 2	876.4370	2013-02-04
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2025-01-29
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2020-12-11
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2018-06-07
FLD	Apparatus, Hemoperfusion, Sorbent	Gastroenterology, Urology	Class 2	876.5870	2018-06-07
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2013-02-04
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2025-05-14
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2022-11-15
MDP	Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma	Unknown	Class 3	N/A	2026-05-05
OOD	Surgical Film	General, Plastic Surgery	Class 2	878.3300	2024-02-14
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2024-02-14
OWT	Mesh, Surgical, Absorbable, Abdominal Hernia	General, Plastic Surgery	Class 2	878.3300	2024-02-14
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2013-01-25
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2022-07-05
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2020-12-11
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	Class 1	886.4360	2013-02-04
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2013-01-03
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2026-03-19
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-02-04
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2018-06-07
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2015-04-01
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2013-01-03
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2019-12-13
PFO	Active Implantable Bone Conduction Hearing System	Ear, Nose, Throat	Class 2	874.3340	2025-12-08
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2021-12-27
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2024-06-03
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2022-05-19
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2013-02-04
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2014-01-21
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2026-02-25
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2026-06-08
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2024-10-22
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
1000286794	STERLAB	VALLAURIS Alpes-Maritimes, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K220540	Covidien	ProGrip Self-Gripping Polypropylene Mesh	2022-09-22
K033719	C.R. Bard, Inc.	BARD TIGERTAIL URETERAL CATHETER	2004-02-04
K820239	American Endoscopy, Inc.	RETRIEVAL FORCEPS	1982-03-26
K041243	Tyco Healthcare	DOVER RED RUBBER ROBINSON CATHETER	2004-07-07
K873288	Todd Medical, Inc.	CLOSED FOLEY CATHETER SYSTEM	1987-11-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2013	C.R. Bard, Inc., Urological Division	2	8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006174295. Last updated year: 2026. Please use registration number 3006174295 when referencing this establishment in official correspondence.