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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

10001093 — Class III MDD by Fidia Farmaceutici S.p.A.

MD Atlas
Fidia Farmaceutici S.p.A.

EUDAMED last updated this device on Apr 27, 2026

10001093

B-1000109339

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Fidia Farmaceutici S.p.A.
UDI-DI code: D-1000109339
Reference / catalog number: 10001093

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View device family (Basic UDI)

Manufacturer information

Organization name: Fidia Farmaceutici S.p.A.
SRN: IT-MF-000026988
Manufacturer status: Active

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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.

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW009
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.
CW032
EUDAMED did not publish a description for this code.
CW275
EUDAMED did not publish a description for this code.
CW999
Do not administer to patients with ascertained individual hypersensitivity to the product components.
CW999
Do not administer in cases of infections or skin diseases in the area of the injection site.
CW999
Do not administer to patients with active synovitis.
CW999
The assembled syringe must be discarded immediately after use, regardless of whether or not the solution has been completely administered.

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Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Dec 31, 2027

Device identification

Trade name: not provided
UDI-DI code: D-1000109339
Basic UDI-DI: B-1000109339
Reference / catalog number: 10001093
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: 60 mg/4 ml

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

D-1000109339

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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