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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

1629 — Class I MDR by FARMABAN s.a.

MD Atlas
FARMABAN s.a.

EUDAMED last updated this device on Dec 13, 2024

1629

8428012NEUROTAPESA

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: FARMABAN s.a.
UDI-DI code: 08428012016291
Reference / catalog number: 1629

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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

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

CW010
EUDAMED did not publish a description for this code.
CW999
PRECAUTIONS Do not apply on damaged skin and/or wounds. When applying make sure that no vasoconstriction occurs in the skin and that the bandage is not too tight. In case of pregnancy consult your doctor before use. Do not use the bandage in combination or interaction with other treatments. The product is for single use only and must be used by qualified personnel. Do not reuse. Reuse can alter the functionality and properties of the product and cause an infection to the patient. If you observe signs of skin irritation lasting more than 30 minutes (itching, redness or rashes) or if pain persists or in case of other symptoms, remove the bandage immediately as indicated in the instructions for use. If necessary, consult a doctor or a health care professional. If you observe unexpected or potentially serious symptoms after using this product, please inform your doctor or pharmacist, the manufacturer and the competent authority of the Member State in which the user and/or patient are established. CONTRAINDICATIONS Do not use in case of thrombosis or thrombophlebitis, occlusive peripheral vascular disease or in case of malignant tumors, radiation or chemotherapy. Do not use in case of acute and chronic skin diseases. The product should not be used in case of known hypersensitivity to any of the components.

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: 08428012016291
Basic UDI-DI: 8428012NEUROTAPESA
Reference / catalog number: 1629
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: 5 MU10
5 MU36
Beige

EMDN nomenclature code(s)

M03040299ELASTIC SUPPORT BANDAGES - 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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification