Unodent

by Falcon Surgical Co. (Pvt.) Ltd 450 variants

Ref IIU215

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number++G120ImpressionTrayWJ Basic UDI-DI +G120IIU21505UDI-DI	Date9 May 2026Registered	StatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name: Impression Trays
Model / reference: IIU215

Primary DI / UDI-DI: +G120IIU21505
Basic UDI-DI: ++G120ImpressionTrayWJ
EMDN code: Q010207 Dental impression devices for prosthetic dentistry

Device class: Class I
EU registration type: Standard device
EU market of registration: Italy

Manufacturer details

EUDAMED SRN: PK-MF-000018125
Authorised representative: CMC Medical Devices & Drugs SL ES-AR-000000293

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Properties

Sterilise before use

Other properties (13)

Supplied sterile: No
Implantable: No
Reusable: No
Contains latex: No
Reprocessed single-use device: No
Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
Incorporates a substance derived from human blood or plasma: No
Contains human tissues or cells: No
Contains animal tissues or cells: No
Contains endocrine-disrupting substances: No
Administering medicine: No
Measuring function: No
Incorporates a medicinal substance: No