Koelis
Active in EUDAMEDFrancefrom SRN EUDAMED FDA SRN FR-MF-000000830 FEI 3008487708
Koelis is a medical device manufacturer based in France, with 44 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class I and IIa) as of 14 Nov 2026.
- Devices
- 44
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 32
- EUDAMED 31
- FDA 510(k) 4
- Device classes
- FDA Class II 23
- EU Class I 20
- EU Class IIa 1
- Top EMDN categories
- Identifiers
- EUDAMED SRN FR-MF-000000830
- FDA FEI 3008487708
- DUNS 290318455
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- United States
- FDA FEI
What Koelis makes
Koelis manufactures reusable needle guides, manually-adjusted surgical instrument assist arms, and general-purpose ultrasound imaging systems. Their product line includes specialized supports for 3D endocavity ultrasound probes, such as side-fire and end-fire variants, as well as reusable guidance perineal nails and biopsy needles in 14G and 18G sizes. They also provide software for image segmentation to enhance ultrasound imaging.
Koelis’ devices are classified under EU Class I, Class II, and Class IIa, with listings in the EUDAMED registry, FDA’s 510(k) clearance database, and FDA’s Unique Device Identifier (UDI) system. The company is based in France.
Catalogue
Search and filter all 44 devicesCompany details
- EUDAMED SRN
- FR-MF-000000830
- FDA FEI number
- 3008487708
- DUNS number
- 290318455
- EU VAT number
- FR81492218375
- EUDAMED status
- Active
- EUDAMED registered name
- KOELIS
- Registered address
- 22, Chemin du vieux chêne, 38240, MEYLAN, France
- Website
- koelis.com/
- info@koelis.com
- Phone
- +33458176811
- PRRC contact
- Laurence WARIN-SIMON
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 7 Jan 2030
GMED SAS 0459 2 certificates
- 40180 Active
Quality management system EU MDR
- Issued
- 20 Oct 2026
- Expires
- 19 Mar 2030
- Reason
- Add device or group
- 40107 Active
Quality management system EU MDR
- Issued
- 29 Sep 2026
- Expires
- 7 Jan 2030
- Reason
- Other
Frequently asked questions
How many devices does KOELIS have in the registry?
The registry currently lists 44 devices for KOELIS. Devices recorded under merged duplicate company entries are counted once.
Which registries list KOELIS's devices?
Among its 44 most recently registered devices, KOELIS has devices listed in EUDAMED (31 devices), FDA 510(k) (4 devices) and FDA GUDID (32 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do KOELIS's devices fall under?
Among its 44 most recently registered devices, the classes recorded for KOELIS's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for KOELIS?
EUDAMED lists 2 certificates for KOELIS (quality management system) under MDR. The most recent was issued on 20 Oct 2026.
What are the newest devices from KOELIS in the registry?
The most recently registered devices listed for KOELIS include Lin-Lead, Steady Pro for Full-3D endocavity end-fire probe, Steady Pro support for Full-3D endocavity side-fire probe and Steady Pro support for Full-3D endocavity end-fire probe.