MEDISTRI SA

FDA Device Registration & Listing · Domdidier Fribourg, CH · Registration 3006946276

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006946276
FEI Number
3006946276
Entity Name
MEDISTRI SA
City/State/Country
Domdidier Fribourg, CH
Establishment Address
Route de l'industrie, 96, Domdidier Fribourg 1564, CH
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
Medistri SA (Owner Number: 10024700)
Owner / Operator Contact Address
Route de l'industrie, 96, Domdidier, CH-FR 1564, CH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-04-12
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2017-11-15
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2025-12-17
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2025-12-17
SBF Orthopedic Augmented Reality Neurology Class 2 882.4560 2021-04-12
SDQ Alfapump System Unknown Class 3 N/A 2025-06-25
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2013-08-07
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2013-08-07
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-04-12
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2022-03-10
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-03-10
NIP Stent, Superficial Femoral Artery Unknown Class 3 N/A 2019-01-25
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-04-18
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2020-04-16
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2020-04-16
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-08-07
SDD Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field General, Plastic Surgery Class 2 878.4965 2026-01-16
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-08-07
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2017-11-15
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2013-12-09
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2020-01-20
MSS Folders And Injectors, Intraocular Lens (Iol) Ophthalmic Class 1 886.4300 2015-07-22
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2026-02-12
MSS Folders And Injectors, Intraocular Lens (Iol) Ophthalmic Class 1 886.4300 2014-12-18
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2023-07-26
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2023-07-26
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-04-18
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2024-02-08
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2024-02-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-02-17
ONU Drug-Eluting Peripheral Transluminal Angioplasty Catheter Unknown Class 3 N/A 2017-03-27
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2017-11-15
OWX Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon General, Plastic Surgery Class 2 878.3300 2026-05-05
SBF Orthopedic Augmented Reality Neurology Class 2 882.4560 2023-02-17
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-02-17
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-04-12
HQL Intraocular Lens Ophthalmic Class 3 886.3600 2019-04-10
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2021-04-12
OOE Ophthalmic Femtosecond Laser Ophthalmic Class 2 886.4390 2019-01-10
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2020-01-20
PBF Orthopaedic Surgical Planning And Instrument Guides Orthopedic Class 2 888.3030 2024-04-18
SBF Orthopedic Augmented Reality Neurology Class 2 882.4560 2024-04-18
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2024-04-18
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2023-02-14
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2013-08-07
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2013-08-07
MSS Folders And Injectors, Intraocular Lens (Iol) Ophthalmic Class 1 886.4300 2014-12-18
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-03-10
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-03-10
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2020-01-20
OWX Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon General, Plastic Surgery Class 2 878.3300 2025-03-13
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2025-07-24
SBF Orthopedic Augmented Reality Neurology Class 2 882.4560 2023-02-17
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2026-02-12
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2013-08-07
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2018-05-30
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2018-05-30
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2013-08-07
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-02-17
MSS Folders And Injectors, Intraocular Lens (Iol) Ophthalmic Class 1 886.4300 2014-12-18
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2023-02-17
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2020-01-20
FRO Dressing, Wound, Drug Unknown Class U N/A 2022-01-27
JDK Prosthesis, Hip, Cement Restrictor General, Plastic Surgery Class 2 878.3300 2023-02-17
PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown Class 3 N/A 2024-02-06
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2017-11-21
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2017-11-21
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2017-11-21
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-08-07
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2014-06-05
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2015-12-16
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2015-12-16
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2015-12-16
HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered Ophthalmic Class 2 886.4150 2014-12-15
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2014-12-15
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-08-07
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-08-07
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2026-02-12
MSS Folders And Injectors, Intraocular Lens (Iol) Ophthalmic Class 1 886.4300 2014-12-18
SBF Orthopedic Augmented Reality Neurology Class 2 882.4560 2023-02-17
MSS Folders And Injectors, Intraocular Lens (Iol) Ophthalmic Class 1 886.4300 2025-12-17
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-02-17
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-08-07
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2023-01-27
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2023-01-27

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Medistri SA
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
K193295 Parcus Medical, LLC Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor 2020-01-23
K193606 Conmed Corporation Y-Knot OneStep Anchor 2020-01-22
K984200 R. Thomas Grotz, M.D., Inc. STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE 1999-01-21
K171060 Riverpoint Medical OrthoButton AL 2017-06-02
K231867 Paragon 28, Inc. Grappler Suture Anchor System 2023-08-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0030-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0007-2014 Bard Peripheral Vascular Inc 3
Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX062003CL, EX072003CL. The LifeStent Solo Vascular Stent System is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (SFA) and in the proximal popliteal artery with reference vessel diameters ranging from 4.0 6.5 mm.
Z-0001-2019 Smith & Nephew, Inc. 2
Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Z-0002-2019 Smith & Nephew, Inc. 2
JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006946276. Last updated year: 2026. Please use registration number 3006946276 when referencing this establishment in official correspondence.
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