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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

1118 — Class I MDR by FARMABAN s.a.

MD Atlas
FARMABAN s.a.

EUDAMED last updated this device on Dec 13, 2024

1118

8428012V202-01-10W9

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: FARMABAN s.a.
UDI-DI code: 08428012011180
Reference / catalog number: 1118

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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
CONTRAINDICATIONS: Do not use in case of diabetes, vascular problems and edemas. Do not use in case of known hypersensitivity to any of its components. PRECAUTIONS: Always apply the bandage on clean and dry skin. Do not apply in case of skin fragility or directly on a wound. For the fixation of dressings, apply the bandage without tension and gently from the center of the dressing towards the ends. Never fix one end and pull the bandage to secure the opposite end (it can cause skin lesions).

Market distribution

Primary placement in Spain; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08428012011180
Basic UDI-DI: 8428012V202-01-10W9
Reference / catalog number: 1118
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 2.7 MU36
7.5 MU10

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