Sterylab S.r.l.
Active in EUDAMEDItalyfrom SRN EUDAMED FDA SRN IT-MF-000015830 FEI 3007748770
- Devices
- 534
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
3 of 4 in force.
Market reach
- European Union
- EUDAMED actor, 4 certificates
- United States
- FDA FEI
What Sterylab S.r.l. makes
STERYLAB S.R.L. makes bone biopsy devices such as MIELO-CAN, BEST-LISAS, and BEN, as well as soft tissue biopsy devices including FAST-CUT, COLT, SPRING-CUT, and BIO-CUT. The company also produces the DRJ2006 device.
The manufacturer's portfolio includes Class II and Class III devices, which are listed in the EUDAMED registry and the FDA 510(k) database. STERYLAB S.R.L. is based in Italy.
Catalogue
Search and filter all 534 devicesShowing 1-50 of 534
Company details
- EUDAMED SRN
- IT-MF-000015830
- FDA FEI number
- 3007748770
- EU VAT number
- 10124260158
- EUDAMED status
- Active
- EUDAMED registered name
- STERYLAB S.R.L.
- Registered address
- 77/6, Via Magenta, 20017, Rho, Italy
- [email protected]
- Phone
- +39 0293508427
- PRRC contact
- Flavio Zambelli
EUDAMED certificates
4 certificates3 valid, 0 expired, 1 withdrawn or suspendedMDR 4next expiry 7 Sep 2027
ITALCERT SRL 0426 4 certificates
- 030-00-00-MDR Active
Quality assurance EU MDR
- Issued
- 29 Aug 2023
- Expires
- 28 Aug 2028
- 012-00-01-MDR Active
Technical documentation EU MDR
- Issued
- 27 Mar 2026
- Expires
- 6 Feb 2028
- Reason
- Other
- 003-00-11-MDR Expiring
Quality management system EU MDR
- Issued
- 29 Sep 2025
- Expires
- 7 Sep 2027
- Reason
- Add device or group
- 011-00-00-MDR Withdrawn
Quality management system EU MDR
- Issued
- 7 Feb 2023
- Expires
- 6 Feb 2028
- Reason
- Other
Frequently asked questions
How many devices does STERYLAB S.R.L. have in the registry?
The registry currently lists 534 devices for STERYLAB S.R.L.. Devices recorded under merged duplicate company entries are counted once.
Which registries list STERYLAB S.R.L.'s devices?
Among its 50 most recently registered devices, STERYLAB S.R.L. has devices listed in EUDAMED (50 devices).
What risk classes do STERYLAB S.R.L.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for STERYLAB S.R.L.'s devices are Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for STERYLAB S.R.L.?
EUDAMED lists 4 certificates for STERYLAB S.R.L. (quality assurance; quality management system; technical documentation) under MDR. 1 is recorded with the status issued. The most recent was issued on 27 Mar 2026.
What are the newest devices from STERYLAB S.R.L. in the registry?
The most recently registered devices listed for STERYLAB S.R.L. include FULL-OPTY, AGO-GUIDA, TWIN-NEEDLE and AUTO-CORE.