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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

Extensa PLUS — Class I MDR by FARMABAN s.a.

MD Atlas
FARMABAN s.a.

EUDAMED last updated this device on Dec 10, 2024

Extensa PLUS

8428012VF503-201AS

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: FARMABAN s.a.
UDI-DI code: 08428012300611
Reference / catalog number: 928643

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Manufacturer information

Organization name: FARMABAN s.a.
SRN: ES-MF-000004713
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

1 warning recorded — scroll inside the panel to see all entries.

CW999
"COUNTER-INDICATIONS: Do not use in case of arterial problems, severe vascular problems and cases of severe oedema (to the discretion of the medical professional). Hypersensitivity to one of the constituents. PRECAUTIONS: Serious injuries requiring total immobilization. Apply on clean and dry skin. Do not apply in case of damaged skin or directly on skin wounds. Never apply the bandage at maximum tension. In case of numbness or painful sensations remove the bandage and apply it again less tight. If the pain persists or in case of difficulties, ask your pharmacist, physiotherapist or doctor for advice."

Market distribution

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: Extensa PLUS
UDI-DI code: 08428012300611
Basic UDI-DI: 8428012VF503-201AS
Reference / catalog number: 928643
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Hypoallergenic elastic adhesive bandage
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 10 MU10
2.5 MU36

EMDN nomenclature code(s)

M030499ELASTIC BANDAGES, SUPPORT AND COMPRESSION - 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

UDI-PI traceability

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Expiration date
Manufacturing date
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Software identification