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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 — Class I MDR by INNOVACIONES DISRAS SL

MD Atlas
INNOVACIONES DISRAS SL

EUDAMED last updated this device on Oct 15, 2024

OTOSTICK

8437010702006XD

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: INNOVACIONES DISRAS SL
UDI-DI code: 08437010702105
Reference / catalog number: 8437010702105

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Manufacturer information

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

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
UDI-DI code: 08437010702105
Basic UDI-DI: 8437010702006XD
Reference / catalog number: 8437010702105
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: OORCORRIGERENDE PLEISTERS
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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.