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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

Ialest — Class III MDD by Mastelli S.r.l.

MD Atlas
Mastelli S.r.l.

EUDAMED last updated this device on Jan 28, 2025

Ialest

B-8053303261434DDM11EN

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Mastelli S.r.l.
UDI-DI code: D-8053303261434DDM11EN
Reference / catalog number: DDM11BL20XS

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View device family (Basic UDI)

Manufacturer information

Organization name: Mastelli S.r.l.
SRN: IT-MF-000023613
Manufacturer status: Active

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Critical warnings

11 warnings recorded — scroll inside the panel to see all entries.

CW032
EUDAMED did not publish a description for this code.
CW011
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW135
EUDAMED did not publish a description for this code.
CW008
EUDAMED did not publish a description for this code.
CW999
Do not use other products in the same treatment session as IALEST
CW999
As no clinical data are available on the use of the product in patients with autoimmune diseases, in pregnant and lactating women and in subjects under eighteen years of age, treatment with IALEST is not recommended in these cases
CW999
Do not infiltrate IALEST in anatomical sites where infection, dermatitis or inflammatory processes are present

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Jan 1, 2007	Still on market

Device identification

Trade name: Ialest
UDI-DI code: D-8053303261434DDM11EN
Basic UDI-DI: B-8053303261434DDM11EN
Reference / catalog number: DDM11BL20XS
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: Ialest is a viscoelastic, apyrogenic, sterile gel supplied in a pre-filled syringe for single use for intradermal infiltration. Ialest contains hyaluronic acid produced using biotechnology, and is not animal-based.
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

D-8053303261434DDM11EN

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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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.