LimFlow SA
Active in EUDAMEDFrancefrom SRN EUDAMED FDA SRN FR-MF-000011529
LimFlow SA is a medical device manufacturer based in France, with 14 devices listed in EUDAMED (EU Class IIb and IIa) and 1 FDA recall as of 13 Nov 2026.
- Devices
- 14
- Registrations
- EUDAMEDFDA
- FDA recalls
- 11 ongoing
Registry facts
- Registries
- EUDAMED 14
- Device classes
- EU Class IIb 8
- EU Class IIa 6
- Top EMDN categories
- FDA recalls
- Identifiers
- EUDAMED SRN FR-MF-000011529
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- United States
- FDA establishment, FDA recalls
What LimFlow SA makes
LimFlow SA manufactures vascular devices, including the LimFlow Vector—a catheter-based system—and the LimFlow ARC, a stent graft system designed for endovascular repair. The company also produces the LimFlow Stent Graft System, intended for treating peripheral arterial diseases, and the LimFlow V-Ceiver, a diagnostic imaging device for vascular assessment.
The company’s products are classified under EU medical device regulations as Class IIa and Class IIb, with all devices listed in the EU’s eudamed registry. LimFlow SA is based in France and adheres to EU regulatory requirements for these device categories.
Catalogue
Search and filter all 14 devicesCompany details
- EUDAMED SRN
- FR-MF-000011529
- EU VAT number
- FR86820710267
- EUDAMED status
- Active
- EUDAMED registered name
- LimFlow SA
- Registered address
- 15, rue Traversière, 75012, Paris, France
- Website
- limflow.com/int/
- info@limflow.com
- Phone
- +33.638.747.190
- PRRC contact
- Irene Condemi
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 26 Oct 2028
DQS Medizinprodukte GmbH 0297 2 certificates
- 1000261582 Active
Technical documentation EU MDR
- Issued
- 21 Aug 2025
- Expires
- 27 Nov 2028
- 1000261596 Active
Quality management system EU MDR
- Issued
- 21 Aug 2025
- Expires
- 26 Oct 2028
FDA recalls
FDA recall records list 1 recall initiated by LimFlow SA, initiated on 2025-12-05. By recorded status: 1 ongoing. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 1
- 2026 0
2025
- 5 Dec 2025 Z-1218-2026 Class II Ongoing Incorrect expiration date
Full distribution text
- 5 Dec 2025 Z-1218-2026 Class II Ongoing Incorrect expiration date
FDA establishments
- Limflow Inc. Irvine, CA · US FEI 3023527320
From the company website
Don't just worry about surviving amputation. The Limflow procedure helps patients heal wounds while preventing amputation of their feet.
Frequently asked questions
How many devices does LimFlow SA have in the registry?
The registry currently lists 14 devices for LimFlow SA. Devices recorded under merged duplicate company entries are counted once.
Which registries list LimFlow SA's devices?
Among its 14 most recently registered devices, LimFlow SA has devices listed in EUDAMED (14 devices).
What risk classes do LimFlow SA's devices fall under?
Among its 14 most recently registered devices, the classes recorded for LimFlow SA's devices are Class IIa and Class IIb. Each device page shows its own class and authorisation.
Are there FDA recall records for LimFlow SA?
FDA recall records list 1 recall initiated by LimFlow SA, the most recent initiated on 5 Dec 2025. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for LimFlow SA?
EUDAMED lists 2 certificates for LimFlow SA (technical documentation; quality management system) under MDR. 2 are recorded with the status issued. The most recent was issued on 21 Aug 2025.
What are the newest devices from LimFlow SA in the registry?
The most recently registered devices listed for LimFlow SA include LimFlow V-Ceiver, LimFlow Vector, LimFlow ARC and LimFlow Stent Graft System.