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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

TFDM002 — Class IIa MDD by Alfasigma S.p.A.

MD Atlas
Alfasigma S.p.A.

EUDAMED last updated this device on Oct 27, 2022

TFDM002

B-020003233B

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Alfasigma S.p.A.
UDI-DI code: D-020003233B
Reference / catalog number: TFDM002

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Manufacturer information

Organization name: Alfasigma S.p.A.
SRN: IT-MF-000017931
Manufacturer status: Active

Critical warnings

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

CW011
Do not use on already present herpes. It is recommended not to use the product in case of ascertained sensitivity towards one of the components. Device for external use. Device for personal use, do not share with other people. In case of redness or skin irritation, stop the administration and consult your own practitioner. Do not use after the expiration date printed on the package.
CW135
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Dec 15, 2021	May 26, 2024

Device identification

Trade name: not provided
UDI-DI code: D-020003233B
Basic UDI-DI: B-020003233B
Reference / catalog number: TFDM002
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: 5 MU03

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

D-020003233B

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.

M040499DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER

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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Related devices

TFDM001B-0200031134On 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.