Aqua Meron

Ref 1172510(k) K922854

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K922854↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number++E2210720000000000C2 Basic UDI-DI E22111721UDI-DI	Date30 Mar 2026Registered	StatusActive
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Traditional	NumberK922854	Date5 Aug 1992Cleared	StatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

United States FDA 510(k) Active
European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Model / Reference: 1172

Primary DI / UDI-DI: E22111721
Basic UDI-DI: ++E2210720000000000C2
EMDN Code: Q0101010201 Dental base cements

Device Class: Class IIa
EU market of registration: Germany

Manufacturer details

EUDAMED SRN: DE-MF-000008601

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Properties

Implantable

Other properties (12)

Sterile: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No