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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

61ORSP50A — Class I MDD by Europharma Concepts Ltd

MD Atlas
Europharma Concepts Ltd

EUDAMED last updated this device on May 13, 2026

61ORSP50A

B-61ORSP50AZC

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Europharma Concepts Ltd
UDI-DI code: D-61ORSP50AZC
Reference / catalog number: 61ORSP50A

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Manufacturer information

Organization name: Europharma Concepts Ltd
SRN: IE-MF-000024843
Manufacturer status: Active

Critical warnings

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

CW275
If planned for use with children under 12

Market distribution

Primary placement in Ireland; available across 1 country total.

Country	On market since	Until
IrelandPrimary placement	Jan 1, 2017	Still on market

Device identification

Trade name: not provided
UDI-DI code: D-61ORSP50AZC
Basic UDI-DI: B-61ORSP50AZC
Reference / catalog number: 61ORSP50A
Issuing entity: EUDAMED

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Oralieve mouth spray has been specifically formulated to help rebalance oral saliva and provide lasting relief from the symptoms of dry mouth.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 50mL

EMDN nomenclature code(s)

V9017ORAL ADMINISTRATION PREPARATIONS NOT INCLUDED IN OTHER CLASSES

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

Related devices

61ORMG50FEB-61ORMG50FEPGOn the market 61ORMGML12B-61ORMGML12VQOn 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.