Diametros Medical S.r.l. Unipersonale
Active in EUDAMEDItalyfrom SRN EUDAMED SRN IT-MF-000013449
- Devices
- 7
- Registrations
- EUDAMED
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
What Diametros Medical S.r.l. Unipersonale makes
Diametros Medical produces the Lobster Project 2.0, a reusable surgical retractor system designed for minimally invasive procedures. The device is intended for use in orthopaedic, spinal, and trauma surgeries to provide clear access to surgical sites while maintaining stability and reducing tissue trauma.
The Lobster Project 2.0 is classified as both Class IIb and Class III under EU regulations, and it is registered in the EUDAMED database. The company is based in Italy, with operational offices in Florence and Montevarchi.
Catalogue
Lobster Project 2.0 Ref LBT12
Regimes: CE MDR Registry: EUDAMEDLobster Project 2.0 Ref LBT16
Regimes: CE MDR Registry: EUDAMEDLobster Project 2.0 Ref LBS12
Regimes: CE MDR CE MDD Registry: EUDAMEDLobster Project 2.0 Ref LBS10
Regimes: CE MDD Registry: EUDAMEDLobster Project 2.0 Ref LBS14
Regimes: CE MDD Registry: EUDAMEDLobster Project 2.0 Ref LBT08
Regimes: CE MDD Registry: EUDAMEDLobster Project 2.0 Ref LBT12
Regimes: CE MDR CE MDD Registry: EUDAMED
Company details
- EUDAMED SRN
- IT-MF-000013449
- EU VAT number
- 15673341002
- EUDAMED status
- Active
- EUDAMED registered name
- Diametros Medical S.r.l. Unipersonale
- Registered address
- 17, Fra' Domenico Buonvicini, 50132, Firenze, Italy
- Website
- www.diametrosmed.com
- [email protected]
- Phone
- +39055980070
- PRRC contact
- Moira Rossetti
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 8 Dec 2029
TUV Rheinland Italia SRL 1936 2 certificates
- ITH 2290724 1 Active
Quality management system EU MDR
- Issued
- 9 Dec 2024
- Expires
- 8 Dec 2029
- ITI 2290724 1 Active
Technical documentation EU MDR
- Issued
- 9 Dec 2024
- Expires
- 8 Dec 2029
From the company website
Head Office: via Fra’ Domenico Buonvicini 17, 50132 FirenzeOperational Office: via Terranuova 48/5, 52025 Montevarchi (AR)Email: [email protected]: +39 055 980070Fax: +39 055 3909868
Frequently asked questions
How many devices does Diametros Medical S.r.l. Unipersonale have in the registry?
The registry currently lists 7 devices for Diametros Medical S.r.l. Unipersonale. Devices recorded under merged duplicate company entries are counted once.
Which registries list Diametros Medical S.r.l. Unipersonale's devices?
Among its 7 most recently registered devices, Diametros Medical S.r.l. Unipersonale has devices listed in EUDAMED (7 devices).
What risk classes do Diametros Medical S.r.l. Unipersonale's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Diametros Medical S.r.l. Unipersonale's devices are Class IIb and Class III. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Diametros Medical S.r.l. Unipersonale?
EUDAMED lists 2 certificates for Diametros Medical S.r.l. Unipersonale (quality management system; technical documentation) under MDR. 2 are recorded with the status issued. The most recent was issued on 9 Dec 2024.
What are the newest devices from Diametros Medical S.r.l. Unipersonale in the registry?
The most recently registered devices listed for Diametros Medical S.r.l. Unipersonale include Lobster Project 2.0.