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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

Endo IRON — Class IIa MDD by OTOFARMA SPA

MD Atlas
OTOFARMA SPA

EUDAMED last updated this device on May 27, 2026

Endo IRON

B-08057760270039

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: OTOFARMA SPA
UDI-DI code: 08057760270039
Reference / catalog number: Endo IRON

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View device family (Basic UDI)

Manufacturer information

Organization name: OTOFARMA SPA
SRN: IT-MF-000035472
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	May 27, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08057760270039
Basic UDI-DI: B-08057760270039
Reference / catalog number: Endo IRON
Issuing entity: GS1

Classification

Risk category: Class IIa
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.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08057760270039

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Y2145060202HEARING AIDS IN-THE-CANAL (ITC)

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

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Related devices

Retro Micro ATOMB-08057760270114On the market CIC SILVER PLUSB-08057760270060On the market CIC VENUS STANDARDB-08057760270107On the market Retro Micro IRONB-08057760270145On the market CIC IRONB-08057760270084On 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.