Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

0053 — Class III MDD by AERAZEN LAB SRL

MD Atlas
AERAZEN LAB SRL

EUDAMED last updated this device on Mar 16, 2026

0053

B-8059020390099Z6

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: AERAZEN LAB SRL
UDI-DI code: D-8059020390099Z6
Reference / catalog number: 0053

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

View device family (Basic UDI)

Manufacturer information

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

Related devices

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.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Jan 1, 2020	Dec 31, 2027

Device identification

Trade name: not provided
UDI-DI code: D-8059020390099Z6
Basic UDI-DI: B-8059020390099Z6
Reference / catalog number: 0053
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: 2 MU03

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

D-8059020390099Z6

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

Become a partner of MD Atlas