Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004756681

FEI Number

3004756681

Entity Name

ANALYTIC BIOSURGICAL SOLUTIONS (ABISS)

City/State/Country

Saint-Etienne Loire, FR

Establishment Address

25 Rue Du Vercors, 14 Rue De La Telematique, Saint-Etienne Loire 42000, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ANALYTIC BIOSURGICAL SOLUTIONS (ABISS) (Owner Number: 9056816)

Owner / Operator Contact Address

14 RUE DE LA TELEMATIQUE, --, SAINT-ETIENNE, FR-NOTA 42000, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MENTOR ARIS TRANS-OBTURA ARIS SUPRIS SUPRIS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2005-06-15
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2024-09-11

Official Correspondent

No official correspondent registered.

US Agent Details

KEVIN WALLS Business: REGULATORY INSIGHT INC Email: Kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

ANALYTIC BIOSURGICAL SOLUTIONS (ABISS)

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K222293	Urocure, LLC	ArcSP Suprapubic Sling System	2022-09-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004756681. Last updated year: 2026. Please use registration number 3004756681 when referencing this establishment in official correspondence.