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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

0163 — Class III MDD by AERAZEN LAB SRL

MD Atlas
AERAZEN LAB SRL

EUDAMED last updated this device on Mar 17, 2026

0163

B-8059020390396ZF

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: AERAZEN LAB SRL
UDI-DI code: D-8059020390396ZF
Reference / catalog number: 0163

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View device family (Basic UDI)

Manufacturer information

Organization name: AERAZEN LAB SRL
SRN: IT-MF-000028400
Manufacturer status: Active

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0096B-8059020390228YROn the market 0097B-8059020390235YNOn the market 0071B-8059020390297ZCOn the market 0072B-8059020390280YTOn the market 0263B-8059020390730Z5On 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.

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	Jul 8, 2020	Dec 31, 2027

Device identification

Trade name: not provided
UDI-DI code: D-8059020390396ZF
Basic UDI-DI: B-8059020390396ZF
Reference / catalog number: 0163
Issuing entity: EUDAMED

Classification

Risk category: Class III
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: 1 MU03

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

D-8059020390396ZF

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

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

P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES

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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