Bioplax Italia SRL
Active in EUDAMEDItalyfrom SRN EUDAMED FDA SRN IT-MF-000032128 FEI 3029906643
- Devices
- 5
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
Catalogue
Aftamed junior gel Ref AF05000101000
Regimes: CE MDR Registry: EUDAMEDAftamed Plus Forte spray Ref AF02200302000
Regimes: CE MDR Registry: EUDAMEDAftamed plus forte gel Ref PA06000100800
Regimes: CE MDR Registry: EUDAMEDAftamed Theething gel Ref AF08000101000
Regimes: CE MDR Registry: EUDAMEDAftamed gel Ref AF01000101000
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- IT-MF-000032128
- FDA FEI number
- 3029906643
- EU VAT number
- 05642700966
- EUDAMED status
- Active
- EUDAMED registered name
- Bioplax Italia Srl
- Registered address
- 21, Via G. Leopardi, 20123, Milano, Italy
- [email protected]
- Phone
- +390243910219
- PRRC contact
- Mariagiulia Biscaro
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 17 Sep 2030
IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. 0051 1 certificate
- 219/MDR Active
Quality management system EU MDR
- Issued
- 18 Sep 2025
- Expires
- 17 Sep 2030
Frequently asked questions
How many devices does Bioplax Italia Srl have in the registry?
The registry currently lists 5 devices for Bioplax Italia Srl. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bioplax Italia Srl's devices?
Among its 5 most recently registered devices, Bioplax Italia Srl has devices listed in EUDAMED (5 devices).
What risk classes do Bioplax Italia Srl's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Bioplax Italia Srl's devices are Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Bioplax Italia Srl?
EUDAMED lists 1 certificate for Bioplax Italia Srl (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2025-09-18.
What are the newest devices from Bioplax Italia Srl in the registry?
The most recently registered devices listed for Bioplax Italia Srl include Aftamed junior gel, Aftamed Plus Forte spray, Aftamed plus forte gel and Aftamed Theething gel.