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Amalgam Gun

by Larident SRL 3 variants

Part of a family of 10 devices: see the family page

Ref A13

Amalgam Gun (A13) is a Class I device made by Larident SRL, registered in EUDAMED on 22 Apr 2026 (Basic UDI-DI 805350498A/SIRINGA4N), active as of 22 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805350498A/SIRINGA4N Basic UDI-DI 08053504989601UDI-DIDate22 Apr 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Amalgam Carrier Syringe
Model / reference
A13
Primary DI / UDI-DI
08053504989601
Basic UDI-DI
805350498A/SIRINGA4N
Direct marketing DI
08053504989601
EMDN code
A13 Applicators for drugs and medical devices not present in other classes
Device class
Class I
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000007807

Similar devices in this category

Other devices filed under APPLICATORS FOR DRUGS AND MEDICAL DEVICES NOT PRESENT IN OTHER CLASSES.

Other devices from Larident SRL

See all devices from Larident SRL →

Properties

  • Sterilise before use
Other properties (13, all answered No)