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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

Prorhinel — Class I MDD by Laboratoire de la Mer

MD Atlas
Laboratoire de la Mer

EUDAMED last updated this device on Apr 3, 2024

Prorhinel

B-05054563909336

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Laboratoire de la Mer
UDI-DI code: 05054563909336
Reference / catalog number: OH1850020

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Manufacturer information

Organization name: Laboratoire de la Mer
SRN: FR-MF-000009050
Manufacturer status: Active

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LABMER-001/A-15B-03564300001015On the market OH1022030/OH2148030B-03564300001008On the market OH21132020B-08710537044546On the market OH1758100356430LABMER-004/A-H6On the market OH2411100356430LABMER-002/C-GWOn 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.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Sep 10, 2018	Apr 3, 2024

Device identification

Trade name: Prorhinel
UDI-DI code: 05054563909336
Basic UDI-DI: B-05054563909336
Reference / catalog number: OH1850020
Issuing entity: GS1

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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q030103NASAL IRRIGATION SOLUTIONS

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

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Software identification