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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

31535 — Class I MDR by GIMA SPA

MD Atlas
GIMA SPA

EUDAMED last updated this device on May 29, 2026

31535

8023279Z1214900600000002X

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GIMA SPA
UDI-DI code: 08023279315356
Reference / catalog number: 31535

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View device family (Basic UDI)

Manufacturer information

Organization name: GIMA SPA
SRN: IT-MF-000011004
Manufacturer status: Active

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315828023279Z121201140000000Q9On the market 31537802327900L1603033500000V5On the market 31584802327900L1603033500000V5On the market 315808023279Z1214900600000002XOn the market 25621802327900L14909900000007BOn the market

Certificates

Certificate health across this manufacturer's portfolio.

IT349382Issued
Quality assuranceNotified body: 1370Expiry: Jan 26, 2030

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 2 countries total.

Country	On market since	Until
ItalyPrimary placement		Still on market
Spain		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08023279315356
Basic UDI-DI: 8023279Z1214900600000002X
Reference / catalog number: 31535
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: 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

EMDN nomenclature code(s)

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

Z12149006DIRECT OUTPATIENT OTOSCOPES

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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