Bios SRL
Active in EUDAMEDItalyfrom SRN EUDAMED SRN IT-MF-000022514
- Devices
- 7
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What Bios SRL makes
BIOS SRL manufactures vaginal dilators, including the Feminess Tip and NuEra Tight Feminess, designed for pelvic floor rehabilitation and muscle training. They also produce the OptiPLUS, a device intended for vaginal wall stimulation and therapeutic exercises. These products are intended for clinical and home use to support pelvic health and recovery.
The company’s devices fall under EU Medical Device Regulation (MDR) as Class IIb products and are registered in the EU’s eudamed database. BIOS SRL operates from Italy, adhering to EU regulatory requirements for medical devices.
Catalogue
- CE MDD EUDAMED
Splendor X Ref APMD122.SPX-2.0
CE MDR EUDAMED- CE MDD EUDAMED
NuEra Tight Ref APMD145-1ch
CE MDR EUDAMEDFeminess Tip Ref AE0204
CE MDR EUDAMEDGUDIDOptiPLUS Ref APMD145-1ch-OptiPLUS
CE MDR EUDAMEDNuEra Tight Feminess Ref APMD145-1chv
CE MDR EUDAMED
Company details
- EUDAMED SRN
- IT-MF-000022514
- DUNS number
- 443571203
- EU VAT number
- IT02721570964
- EUDAMED status
- Active
- EUDAMED registered name
- BIOS Srl
- Registered address
- 10/12, Via Guido Rossa, 20055, Vimodrone, Italy
- Website
- www.biosgroup.eu
- [email protected]
- Phone
- +39 0227304275
- PRRC contact
- Riccardo Valle
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 24 Aug 2030
Notified body 0051 1 certificate
- 237/MDR Issued
Quality management system EU MDR
- Issued
- 25 Aug 2025
- Expires
- 24 Aug 2030
Frequently asked questions
How many devices does BIOS SRL have in the registry?
The registry currently lists 7 devices for BIOS SRL. Devices recorded under merged duplicate company entries are counted once.
Which registries list BIOS SRL's devices?
Among its 7 most recently registered devices, BIOS SRL has devices listed in EUDAMED (7 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do BIOS SRL's devices fall under?
Among its 7 most recently registered devices, the classes recorded for BIOS SRL's devices are Class IIa and Class IIb. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for BIOS SRL?
EUDAMED lists 1 certificate for BIOS SRL (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2025-08-25.
What are the newest devices from BIOS SRL in the registry?
The most recently registered devices listed for BIOS SRL include APMD145-1ch, SPLENDOR X, APMD122.SPX-1.9 and NuEra Tight.