Helix Surgical SAS
Active in EUDAMEDFrancefrom SRN EUDAMED SRN FR-MF-000009344
- Devices
- 3
- Registrations
- EUDAMED
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
Catalogue
Rx Ref IDEM-0001
Regimes: CE MDR Registry: EUDAMEDPatient Interface Ref A0505 / CCOM-0003
Regimes: CE MDR Registry: EUDAMEDRx Ref A0503 / DCOM-0001
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- FR-MF-000009344
- EU VAT number
- FR24848010476
- EUDAMED status
- Active since 2023
- EUDAMED registered name
- HELIX SURGICAL SAS
- EUDAMED abbreviated name
- HELIX SURGICAL
- Registered address
- 27, Allée Charles Darwin, 33600, Pessac, France
- Website
- www.helixsurgical.com
- [email protected]
- Phone
- +33 5 64 31 19 30
- PRRC contact
- Alizée MARECZKO
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 29 Oct 2028
GMED SAS 0459 2 certificates
- 39458 Active
Quality management system EU MDR
- Issued
- 22 Jul 2026
- Expires
- 29 Oct 2028
- Reason
- Mnf data change
- 39493 Active
Quality management system EU MDR
- Issued
- 22 Jul 2026
- Expires
- 29 Oct 2028
- Reason
- Mnf data change
From the company website
Discover Rx, the new femtosecond laser for performing a perfect capsulotomy in cataract surgery. Rx is the new innovation of Helix Surgical.
Frequently asked questions
How many devices does HELIX SURGICAL SAS have in the registry?
The registry currently lists 3 devices for HELIX SURGICAL SAS. Devices recorded under merged duplicate company entries are counted once.
Which registries list HELIX SURGICAL SAS's devices?
Among its 3 most recently registered devices, HELIX SURGICAL SAS has devices listed in EUDAMED (3 devices).
What risk classes do HELIX SURGICAL SAS's devices fall under?
Among its 3 most recently registered devices, the classes recorded for HELIX SURGICAL SAS's devices are Class I and Class IIb. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for HELIX SURGICAL SAS?
EUDAMED lists 2 certificates for HELIX SURGICAL SAS (quality management system) under MDR. The most recent was issued on 22 Jul 2026.
What are the newest devices from HELIX SURGICAL SAS in the registry?
The most recently registered devices listed for HELIX SURGICAL SAS include RX and PATIENT INTERFACE.