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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

10000251 — Class IIa MDD by Fidia Farmaceutici S.p.A.

MD Atlas
Fidia Farmaceutici S.p.A.

EUDAMED last updated this device on Apr 10, 2026

10000251

B-100002512U

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Fidia Farmaceutici S.p.A.
UDI-DI code: D-100002512U
Reference / catalog number: 10000251

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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

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

CW999
HYDEAL CYST+ is advised for use in suitably hygienic environments and by healthcare staff that are suitably informed regarding bladder instillation treatment.
CW999
Product functionality is only guaranteed by the integrity of the primary and secondary packaging (syringe and pouch).
CW999
Do not administer to patients with known hypersensitivity reactions. Discontinue use if adverse reactions occur and consult your doctor if symptoms persist.
CW999
As clinical evidence on the use of Hyaluronic Acid in babies, pregnant women and breast-feeding women is not available, treatment with this protective preparation in these patients is not recommended
CW999
Do not dispose of empty containers into the environment
CW010
EUDAMED did not publish a description for this code.
CW999
Single use product: use the entire contents of the pre-filled syringe for each individual application
CW999
Sterile product: If the solution is reused, sterility is no longer guaranteed and can become a vehicle for infection
CW999
Dispose of in accordance with current legislation.
CW999
Keep out of reach of children
CW999
Not for parenteral administration

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Market distribution

Primary placement in Italy; available across 2 countries total.

Country	On market since	Until
ItalyPrimary placement		Dec 31, 2028
Czechia		Dec 31, 2028

Device identification

Trade name: not provided
UDI-DI code: D-100002512U
Basic UDI-DI: B-100002512U
Reference / catalog number: 10000251
Issuing entity: EUDAMED

Classification

Risk category: Class IIa
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: 50 MU48

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

D-100002512U

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.

U1301SOLUTIONS FOR BLADDER WASHING AND INSTILLATION

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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