Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006617533

FEI Number

3006617533

Entity Name

PROMEPLA S.A.M

City/State/Country

MONACO Monaco-Ville, MC

Establishment Address

9 AVENUE PRINCE ALBERT II, MONACO Monaco-Ville 98000, MC

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PROMEPLA (Owner Number: 9092365)

Owner / Operator Contact Address

9 AVENUE ALBERT II, --, MONACO, MC-MO 98000, MC

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Swiss LithoClast® Trilogy ulrichINJECT CT motion tubing set Tubing, with filter, sterile, for insufflation Hunter Scientific Pasteur Pipette PPB150-100; Hunter Scientific Pasteur Pipette PPB150-100PL; Hunter Scientific Pasteur ulricheasyINJECT Tubing, sterile, for UIII smoke evaluation Stone catcher with tubing and adapter Stone Catcher for Swiss LithoClast® Trilogy

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FFK	Lithotriptor, Electro-Hydraulic	Gastroenterology, Urology	Class 2	876.4480	2023-04-26
FEO	Lithotriptor, Ultrasonic	Gastroenterology, Urology	Class 2	876.4480	2023-04-26
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2026-01-21
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2026-01-08
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2007-08-01
PUC	Microtools, Assisted Reproduction (Pipettes), Exempt	Obstetrics/Gynecology	Class 2	884.6130	2024-10-24
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2024-10-23
FCZ	Tube, Smoke Removal, Endoscopic	Gastroenterology, Urology	Class 1	876.1500	2011-01-25
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2021-12-07
FGO	Dislodger, Stone, Flexible	Gastroenterology, Urology	Class 2	876.4680	2023-04-26

Official Correspondent

kim HERBERT

US Agent Details

Chuck Philipp Email: chuckp@sundance17.net Phone: (720) 3523893

Related Public Records

Same Entity

PROMEPLA

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011816507	EMOTECHNIC	Casablanca, MA
3010659128	PROMEDTECH	Fouchena Tunis, TN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K885255	Candela Laser Corp.	MDL-1 LASERTRIPTER(TM)	1989-06-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2013	US Endoscopy Group Inc	2	Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract.

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3009543101	Ultratellege USA Co. LTD.	Erie, PA, US
3004096429	E.M.S. ELECTRO MEDICAL SYSTEMS S.A.	NYON Vaud, CH
2020550	KARL STORZ ENDOSCOPY-AMERICA, INC.	Auburn, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006617533. Last updated year: 2026. Please use registration number 3006617533 when referencing this establishment in official correspondence.