Regen Lab SA
Active in EUDAMEDSwitzerlandfrom SRN EUDAMED FDA SRN CH-MF-000032231 FEI 3008496303
Regen Lab SA is a medical device manufacturer based in Switzerland, with 58 devices listed in EUDAMED and FDA GUDID (EU Class IIb, IIa and III; FDA Class II) as of 14 Nov 2026.
- Devices
- 58
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- EUDAMED 47
- FDA GUDID 28
- Device classes
- EU Class IIb 32
- FDA Class II 9
- EU Class IIa 8
- EU Class III 7
- Top EMDN categories
- Sites and related companies
- RegenLab France authorised representative
- Identifiers
- EUDAMED SRN CH-MF-000032231
- FDA FEI 3008496303
- DUNS 482206518
At a glance
EU certificates
3 of 3 in force.
Market reach
- European Union
- EUDAMED actor, 3 certificates
- United States
- FDA FEI
- Authorised rep.
- RegenLab FranceFR
What Regen Lab SA makes
REGEN LAB SA manufactures medical devices including haematological concentrate system preparation kits for platelet concentration, venous butterfly needles/sets, and reusable device sterilization/disinfection containers. Specific products include the RegenWound-HA Set, RegenKit®-THT-2, RegenKit®-BCT-4, and various accessory kits.
The company's portfolio includes devices classified as Class II, Class III, Class IIa, and Class IIb, listed in both the EUDAMED and FDA UDI registries. REGEN LAB SA is based in Switzerland (CH).
Catalogue
Search and filter all 58 devicesShowing 1-50 of 58
Company details
- EUDAMED SRN
- CH-MF-000032231
- SRN (system / procedure pack)
- CH-PR-000049402
- FDA FEI number
- 3008496303
- DUNS number
- 482206518
- EUDAMED status
- Active
- EUDAMED registered name
- Regen Lab SA
- Registered address
- Chemin de Budron B2, 1052, Le Mont-sur-Lausanne, Switzerland
- Phone
- +41 21 864 01 11
- PRRC contact
- Daphne Van Diermen
EUDAMED certificates
3 certificates3 valid, 0 expiredMDR 3next expiry 24 Apr 2028
BSI Group The Netherlands B.V. 2797 3 certificates
- MDR 755931 Active
Quality management system EU MDR
- Issued
- 15 Jun 2026
- Expires
- 24 Apr 2028
- Reason
- Other
- MDR 756198 Active
Technical documentation EU MDR
- Issued
- 15 Jun 2026
- Expires
- 24 Apr 2028
- Reason
- Other
- MDR 756199 Active
Technical documentation EU MDR
- Issued
- 15 Jun 2026
- Expires
- 24 Apr 2028
- Reason
- Other
Frequently asked questions
How many devices does REGEN LAB SA have in the registry?
The registry currently lists 58 devices for REGEN LAB SA. Devices recorded under merged duplicate company entries are counted once.
Which registries list REGEN LAB SA's devices?
Among its 50 most recently registered devices, REGEN LAB SA has devices listed in EUDAMED (39 devices) and FDA GUDID (23 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do REGEN LAB SA's devices fall under?
Among its 50 most recently registered devices, the classes recorded for REGEN LAB SA's devices are Class IIa, Class IIb, Class II and Class III. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for REGEN LAB SA?
EUDAMED lists 3 certificates for REGEN LAB SA (quality management system; technical documentation) under MDR. The most recent was issued on 15 Jun 2026.
What are the newest devices from REGEN LAB SA in the registry?
The most recently registered devices listed for REGEN LAB SA include ENKO PRP+HA, RegenWound-HA Set, RegenKit®-THT-2 8495-9-002 and RegenKit®-BCT-4 RK-BCT-4.