DBM SRL
Italy IT-MF-000017565 Last updated 21 Oct 2026
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- Devices
- 7
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
D.B.M. Aquagly Ref PCG08NB1TG
D.B.M. Salineflush Ref PCH06OB1SG
D.B.M. Aquaflush Ref PAG01NB1TG
D.B.M. Salineflush Ref PCG06NB1TG
D.B.M. Aquaflush Ref PCG01MB1TG
D.B.M. C-Lock Ref PCE13KA2
D.B.M. Salineflush Ref PCG06NA1
EUDAMED certificates
ICIM S.P.A. 0425 3 certificates
- 0425-MDR-030158-00 Issued
Quality management system EU MDR
- Issued
- 19 Nov 2025
- Expires
- 18 Nov 2030
- 0425-MDR-030159-00 Issued
Quality management system EU MDR
- Issued
- 19 Nov 2025
- Expires
- 18 Nov 2030
- 0425-MDR-030079-00 Issued
Quality management system EU MDR
- Issued
- 14 Jun 2024
- Expires
- 13 Jun 2029
Related companies
Notified bodies
- ICIM S.P.A. 0425
About
D.B.M. specializes in the production of its own branded pre-filled Syringes and third-party accounts. Contact us for information
What DBM SRL makes
DBM SRL manufactures pre-filled syringes under its own brand, including models such as AQUAGLY, AQUAFLUSH, SALINEFLUSH, and C-LOCK. These products are designed for medical irrigation and saline administration, with some variants incorporating locking mechanisms for secure use.
The company’s devices are classified under Class I and Class IIb per EU regulations and are registered in the euDaMed database. DBM SRL operates from Italy, adhering to EU Medical Device Regulation requirements for listed products.
Frequently asked questions
What types of medical devices does DBM SRL manufacture?
DBM SRL specializes in pre-filled syringes under its own brand, including models like AQUAGLY, AQUAFLUSH, SALINEFLUSH, and C-LOCK. These devices are primarily designed for medical irrigation and saline administration, with some variants featuring locking mechanisms to enhance safety during use.
Where is DBM SRL based, and what regulatory framework does it follow?
DBM SRL is based in Italy. Its devices are developed in compliance with the EU Medical Device Regulations, ensuring they meet the necessary safety, performance, and quality standards for the European market.
Which regulatory registries list DBM SRL’s devices?
DBM SRL’s devices are listed in the euDaMed database, which is the official EU registry for medical devices. This registration helps ensure transparency and traceability of its products under EU regulatory requirements.
How are DBM SRL’s devices classified under EU regulations?
DBM SRL’s devices fall under Class I and Class IIb classifications according to EU Medical Device Regulations. The classification depends on factors like the device’s intended use, risk level, and potential impact on patient safety, with Class IIb indicating a higher risk requiring stricter scrutiny.
What distinguishes DBM SRL’s pre-filled syringes from other similar products?
DBM SRL’s pre-filled syringes are branded and designed specifically for medical irrigation and saline administration, with some models (like C-LOCK) incorporating locking mechanisms to prevent accidental dislodgment or misuse. Their classification as Class I or IIb reflects their intended use and associated risk levels, ensuring compliance with EU safety standards.
Information
- Country
- Italy
- Address
- 2, dell'Industria, Tovo di S.Agata (SO), Italy
- Website
- www.dbmitalia.it
- [email protected]
- Phone
- 0039 342771613
- PRRC contact
- Simona Praolini
- EUDAMED SRN
- IT-MF-000017565