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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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BRUXICALM — 14 UDI-DI variants, MDR (PRIM, S.A.)

MD Atlas
PRIM, S.A.

Data from EUDAMED, last updated May 23, 2026

BRUXICALM

843404825FERULADENTAL2U

14 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class I

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Manufacturer: PRIM, S.A.

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 843404825FERULADENTAL2U
Device name: BRUXICALM
Device model: BCXDAY
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Jun 7, 2022

Manufacturer & authorised representative

Manufacturer

Name: PRIM, S.A.
SRN: ES-MF-000004651
Country: Spain
Email: eudamed1@prim.es
Phone: + 34 91 334 24 00

Variants by status

UDI-DI variants

14 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01G2CPS4G4FPT5FY6TQEY1479Y

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

Anti-bruxism mouthguard day (export) 108434048497287
Anti-bruxism mouthguard day (export) 208434048514502
Anti-bruxism mouthguard night (export) 208434048514496
Anti-bruxism mouthguard night (export)108434048497270
Anti-bruxism mouthguard sport (export) 108434048497294
Anti-bruxism mouthguard sport (export) 208434048514519
BXCDAY/82603608434048365227
BXCLOTE108434048376469
BXCLOTE208434048381098
BXCDAYE08434048408351
BXCNIGHT08434048365258
BXCNIGE08434048408344
BXCSPORT08434048365272
BXCSPOE08434048408368