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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

OTOSTICK BABY — Class I MDR by INNOVACIONES DISRAS SL

MD Atlas
INNOVACIONES DISRAS SL

EUDAMED last updated this device on Oct 10, 2024

OTOSTICK BABY

8437010702006XD

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: INNOVACIONES DISRAS SL
UDI-DI code: 08437010702235
Reference / catalog number: 8437010702235

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Manufacturer information

Organization name: INNOVACIONES DISRAS SL
SRN: ES-MF-000003854
Manufacturer status: Active

Related devices

OTOSTICK8437010702006XDOn the market 84370107020448437010702006XDOn the market 84370107027618437010702006XDOn the market 84370107027788437010702006XDOn the market 84370107024268437010702006XDOn 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 2 countries total.

Country	On market since	Until
FrancePrimary placement		Still on market
Netherlands		Still on market

Device identification

Trade name: OTOSTICK BABY
UDI-DI code: 08437010702235
Basic UDI-DI: 8437010702006XD
Reference / catalog number: 8437010702235
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: 8
Additional product description: CORRECTORES ESTÉTICOS DE OREJAS + 1 GORRO
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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

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Expiration date
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Software identification