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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

F0315PFI — Class I MDR by Fittydent International…

MD Atlas
Fittydent International GmbH

EUDAMED last updated this device on May 18, 2026

F0315PFI

9002240HENZ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fittydent International GmbH
UDI-DI code: 09002240000520
Reference / catalog number: F0315PFI

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Manufacturer information

Organization name: Fittydent International GmbH
SRN: AT-MF-000016986
Manufacturer status: Active

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW999
Suitable for lower dentures only. Do not use on dentures with soft lining. Do not use if you are intolerant against any of the ingredients. Keep out of reach of children.

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 09002240000520
Basic UDI-DI: 9002240HENZ
Reference / catalog number: F0315PFI
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 15
Additional product description: Denture Adhesive Cushions for lower dentures only
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q010280PROSTHETIC DENTISTRY DEVICES - ACCESSORIES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
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Software identification