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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

F0400BES — Class I MDR by Fittydent International…

MD Atlas
Fittydent International GmbH

EUDAMED last updated this device on May 20, 2026

F0400BES

9002240RTvitisSN

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fittydent International GmbH
UDI-DI code: 09002240000032
Reference / catalog number: F0400BES

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Manufacturer information

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

Related devices

fittydent cleansing tablets ORTHODONTIC9002240RTQVOn the market FG140LIT9002240HKPDOn the market fittydent professional Comprimés nettoyants9002240RTQVOn the market fittydent professional Comprimés nettoyants9002240RTQVOn the market fittydent PROFESSIONAL Coussinets auto-adhésifs9002240HENZOn the market

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

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

CW082
EUDAMED did not publish a description for this code.
CW085
EUDAMED did not publish a description for this code.
CW162
EUDAMED did not publish a description for this code.
CW397
EUDAMED did not publish a description for this code.
CW416
EUDAMED did not publish a description for this code.
CW305
EUDAMED did not publish a description for this code.
CW304
EUDAMED did not publish a description for this code.
CW999
Do not put the tablet or cleaning solution in your mouth. Do not drink the cleaning solution or use it as a mouthwash. Do not use in case of intolerance/hypersensitivity to any of the ingredients. Keep out of reach of children.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 09002240000032
Basic UDI-DI: 9002240RTvitisSN
Reference / catalog number: F0400BES
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: 20
Additional product description: Cleansing tablets for removable orthodontic appliances
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q010499ORTHODONTIC DEVICES - OTHER

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
Manufacturing date
Serial number
Software identification