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Organization name
UDI-DI code
Reference / catalog number

Thermoforming sheets 060… — Class I MDR by J RIPOLL SL

MD Atlas
J RIPOLL SL

EUDAMED last updated this device on Apr 17, 2026

Thermoforming sheets 060 Mouthguard 12 Ud Douromed

843604224PLASTMOQ6

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: J RIPOLL SL
UDI-DI code: 08436042241309
Reference / catalog number: 060MDO

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Manufacturer information

Organization name: J RIPOLL SL
SRN: ES-MF-000001256
Manufacturer status: Active

Related devices

020 Temp Splint 50Uds Dentaflux843604224PLASTCLP2On the market 040 Clear 25 Ud Dentaflux843604224PLASTCLP2On the market 040 Mouthguard 12 Ud Dentaflux843604224PLASTMOQ6On the market 040 Mouthguard 12 Ud Douromed843604224PLASTMOQ6On the market 040 Mouthguard 25 Sheets Dentaflux843604224PLASTMOQ6On the market

Market distribution

Primary placement in Portugal; available across 2 countries total.

Country	On market since	Until
PortugalPrimary placement		Still on market
Spain		Still on market

Device identification

Trade name: Thermoforming sheets 060 Mouthguard 12 Ud Douromed
UDI-DI code: 08436042241309
Basic UDI-DI: 843604224PLASTMOQ6
Reference / catalog number: 060MDO
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: 12
Additional product description: 060 Mouthguard 12 Ud Douromed 1.5 MM
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 1.5 MU50

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

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.