Unodent-EU

by Falcon Surgical Co. (Pvt.) Ltd 21 variants

Ref DFO116E

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number++G120Surgicalins43 Basic UDI-DI +G120DFO116E05UDI-DI	Date9 May 2026Registered	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.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Surgical Instruments
Model / Reference: DFO116E

Primary DI / UDI-DI: +G120DFO116E05
Basic UDI-DI: ++G120Surgicalins43
EMDN Code: L99 Surgical instruments, reusable - other

Device Class: Class I
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

Reusable

Other properties (12)

Sterile: No
Implantable: 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