Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010383847

FEI Number

3010383847

Entity Name

STERISERVICES

City/State/Country

Bernay Eure, FR

Establishment Address

20 rue des Canadiens, Bernay Eure 27300, FR

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

STERISERVICES (Owner Number: 10043735)

Owner / Operator Contact Address

20 rue des Canadiens, Bernay, FR-27 27300, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NISSHA GAMBRO INDUSTRIES SOFRADIM PRODUCTION SOFRADIM PRODUCTION TISSIUM 10093777 SOFRADIM PRODUCTION KARL STORZ LUNEAU TONOMETER SEPARATION PRISMS GAMBRO INDUSTRIES SOFRADIM PRODUCTION 10056327 10059918 SOFRADIM PRODUCTION SOFRADIM PRODUCTION PRODIMED SOFRADIM PRODUCTION SOFRADIM PRODUCTION SOFRADIM PRODUCTION 9615742 Sofradim Production SOFRADIM PRODUCTION Sofradim Production SOFRADIM PRODUCTION Molnlycke Health Care US LLC, 3004824904 PRODIMED 3008487708 SOFRADIM PRODUCTION endo tools TITA-LINK SOFRADIM PRODUCTION

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2024-09-24
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2013-03-15
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2025-11-27
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-04-09
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2013-03-15
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-03-15
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	2013-03-15
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2016-07-05
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2025-05-15
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2018-10-19
SFD	In Situ Polymerizing Peripheral Nerve Repair Device	Neurology	Class 2	882.5270	2025-08-27
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2022-10-18
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	Class 1	886.4350	2013-03-15
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2025-12-03
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2014-02-24
HMY	Keratome, Battery-Powered	Ophthalmic	Class 1	886.4370	2013-03-15
HNX	Depressor, Orbital	Ophthalmic	Class 1	886.4350	2013-03-15
FHO	Pneumoperitoneum Needle	Gastroenterology, Urology	Class 2	876.1500	2014-08-25
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2014-08-25
FHP	Needle, Pneumoperitoneum, Simple	Gastroenterology, Urology	Class 2	876.1500	2014-08-25
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2017-07-03
HNO	Keratome, Ac-Powered	Ophthalmic	Class 1	886.4370	2013-03-15
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2025-11-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-03-15
OWT	Mesh, Surgical, Absorbable, Abdominal Hernia	General, Plastic Surgery	Class 2	878.3300	2024-03-18
OOD	Surgical Film	General, Plastic Surgery	Class 2	878.3300	2024-03-18
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2024-03-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-07-05
GZL	Electrode, Depth	Neurology	Class 2	882.1330	2018-01-30
FDC	Resectoscope, Working Element	Gastroenterology, Urology	Class 2	876.1500	2019-08-05
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2019-08-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-08-05
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2022-08-03
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2022-12-15
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2020-01-21
HMY	Keratome, Battery-Powered	Ophthalmic	Class 1	886.4370	2013-04-09
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2013-04-09
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2022-10-18
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2018-10-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-03-15
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2025-02-10
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2018-10-19
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2013-03-15
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2013-03-15
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2013-03-15
HNO	Keratome, Ac-Powered	Ophthalmic	Class 1	886.4370	2013-03-15
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-03-15
DTK	Filter, Intravascular, Cardiovascular	Cardiovascular	Class 2	870.3375	2014-08-25
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2019-12-09
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2016-07-05
OXJ	Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects	General, Plastic Surgery	Class 2	878.3300	2016-07-05
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2016-07-05
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2016-07-05
HMY	Keratome, Battery-Powered	Ophthalmic	Class 1	886.4370	2013-03-15
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-03-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-02-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-03-15
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2017-08-02
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2016-07-05
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2018-01-30
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-03-15
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2020-01-21
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-09-17
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2013-03-15
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2024-01-30
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	2025-05-15
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-03-15
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-04-13
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2014-07-31
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2013-03-15
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2018-10-19

Official Correspondent

PATRICK MONTENOISE

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

STERISERVICES

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

View Entity Profile →

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K150880	Outset Medical	Tablo Console with Wireless Capability	2015-05-01
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
Z-0011-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010383847. Last updated year: 2026. Please use registration number 3010383847 when referencing this establishment in official correspondence.