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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

84353737OTOSPRAYRC — Class I MDD by LABORATORIO REIG JOFRE,…

MD Atlas
LABORATORIO REIG JOFRE, S.A.

EUDAMED last updated this device on Jul 18, 2022

84353737OTOSPRAYRC

B-84353737OTOSPRAYRC6Z

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: LABORATORIO REIG JOFRE, S.A.
UDI-DI code: D-84353737OTOSPRAYRC6Z
Reference / catalog number: 84353737OTOSPRAYRC

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Manufacturer information

Organization name: LABORATORIO REIG JOFRE, S.A.
SRN: ES-MF-000010862
Manufacturer status: Active

Market distribution

Primary placement in Spain; available across 1 country total.

Placed on the market in Spain; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: D-84353737OTOSPRAYRC6Z
Basic UDI-DI: B-84353737OTOSPRAYRC6Z
Reference / catalog number: 84353737OTOSPRAYRC
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: Remove ear wax.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A0699DRAINAGE AND FLUID COLLECTION 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

Related devices

84353737MILROSINA2RB-84353737MILROSINA2RJWOn the market 84353737SUENTILLASYYB-84353737SUENTILLASYY2FOn the market 84353737SUEROFISN5B-84353737SUEROFISN5XVOn 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.