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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

Anti-bruxism mouthguard sport… — Class I MDR by PRIM, S.A.

MD Atlas
PRIM, S.A.

EUDAMED last updated this device on Apr 30, 2026

Anti-bruxism mouthguard sport (export) 2

843404825FERULADENTAL2U

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PRIM, S.A.
UDI-DI code: 08434048514519
Reference / catalog number: BXCSPOE2

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Manufacturer information

Organization name: PRIM, S.A.
SRN: ES-MF-000004651
Manufacturer status: Active

Market distribution

Primary placement in Romania; available across 2 countries total.

Country	On market since	Until
RomaniaPrimary placement	Mar 7, 2025	Still on market
Slovakia	Mar 21, 2025	Still on market

Device identification

Trade name: Anti-bruxism mouthguard sport (export) 2
UDI-DI code: 08434048514519
Basic UDI-DI: 843404825FERULADENTAL2U
Reference / catalog number: BXCSPOE2
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: 1
Additional product description: Serial-manufactured mandibular splint [EN]
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12110101DENTAL TREATMENT UNITS

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

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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.