Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3041276415

FEI Number

3041276415

Entity Name

RAPHARIN

City/State/Country

GENAS Rhone, FR

Establishment Address

3 rue des Freres Lumiere, GENAS Rhone 69740, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

RAPHARIN (Owner Number: 10093986)

Owner / Operator Contact Address

3 rue des Freres Lumiere, GENAS, FR-69 69740, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Neosys single use kit/Neosys single use kit standard/Duafit single use kit/Neomis Standard single use kit/Neomis ANS OS2V IBS C N S/NEOFIT OS2VP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2025-09-01
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-09-01
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2025-09-01
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-09-01

Official Correspondent

Eric GALLAY

US Agent Details

Christine SCIFERT Business: MRC Global Email: christine.scifert@askMRCGlobal.com Phone: (901) 8318053

Related Public Records

Same Entity

RAPHARIN

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
K153770	In2bones Sas	OS2(R)-VP Varisation Staple	2016-03-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2023	Synthes (USA) Products LLC	2	Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001

Similar Registrations

Registration Number	Establishment Name	Location
3016215282	MINDERA CORPORATION	Vista, CA, US
3021006167	KIMS MED CO., LTD.	Gwangju, KR
3022320321	ALIRA MEDICAL DEVICES LLC	Rancho Cucamonga, CA, US
3015225571	Merit Medical Asia Company Limited	Tsim Sha Tsui, HK
2183744	Isomedix Operations, Inc.	Minneapolis, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3041276415. Last updated year: 2026. Please use registration number 3041276415 when referencing this establishment in official correspondence.