0418

Organization name

Metis Healthcare s.r.l.

SRN

IT-MF-000007609

Manufacturer status

Active

3 warnings recorded — scroll inside the panel to see all entries.

• CW275

  Due to the presence of flavonoids in Hibiscus Sabdariffa L. a medical advice is suggested when used during pregnancy.
• CW010

  Salifluss may not be effective in case of complete inactivity of the salivary glands.
• CW011

  Do not go to sleep with the tablet in your mouth.

Primary placement in Spain; available across 6 countries total.

Trade name

not provided

UDI-DI code

D-0418A6

Basic UDI-DI

B-0418A6

Reference / catalog number

0418

Issuing entity

EUDAMED

Risk category

Class I

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Salifluss® is a substance made device, not sterile, invasive (body orifice) and intended to provide pH buccal buffering, helping to maintain the physiological conditions of oral mucosa, and teeth. Salifluss® is also active in the stimulation of saliva production in all that subjects that presents a limited, but not absent, saliva flux from different causes.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

D-0418A6

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER