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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

2048 — Class IIb MDR by FARMA-DERMA S.r.l.

MD Atlas
FARMA-DERMA S.r.l.

EUDAMED last updated this device on Aug 2, 2023

2048

803259587TF01EB

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: FARMA-DERMA S.r.l.
UDI-DI code: 08032595871880
Reference / catalog number: 2048

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Manufacturer information

Organization name: FARMA-DERMA S.r.l.
SRN: IT-MF-000020737
Manufacturer status: Active

Critical warnings

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

CW007
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.
CW135
EUDAMED did not publish a description for this code.
CW999
No debe utilizarse en caso de hipersensibilidad individual a uno de los componentes del producto.
CW999
Se desconocen interacciones con otros productos; por lo tanto, se recomienda que consulte a su médico antes de utilizar CICATRIDINA óvulos vaginales junto con otros productos sanitarios o medicamentos de uso vaginal.
CW999
El empleo de cualquier producto de uso tópico, especialmente si es prolongado, puede causar sensibilización. Si esto ocurre, o si se observan otros efectos secundarios, suspenda el tratamiento y consulte a su médico o farmacéutico.
CW999
El producto es solo para uso vaginal. Evite el contacto con los ojos. No lo trague.
CW999
Si está embarazada o en período de lactancia, dado que no se han realizado estudios clínicos específicos, consulte a su médico antes de utilizar el producto.

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Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Dec 20, 2022	Dec 19, 2027

Device identification

Trade name: not provided
UDI-DI code: 08032595871880
Basic UDI-DI: 803259587TF01EB
Reference / catalog number: 2048
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 3
Additional product description: INDICACIONES. Tratamiento adyuvante de procesos reparadores en condiciones atróficas y distróficas de la mucosa vaginal. Contribuye a la cicatrización en el posparto, en cirugía ginecológica, en casos de distrofia derivados de quimioterapia y radiaciones ionizantes. Tratamiento de la sequedad vaginal de diversos tipos.
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

EMDN nomenclature code(s)

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

U0803VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS

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.