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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

FORMASTRAP — Class I MDR by FARMABAN s.a.

MD Atlas
FARMABAN s.a.

EUDAMED last updated this device on Dec 9, 2024

FORMASTRAP

8428012VF503-201AS

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: FARMABAN s.a.
UDI-DI code: 08428012301328
Reference / catalog number: B32003

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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
CONTRE-INDICATIONS Ne pas utiliser en cas de problèmes artériels, vasculaires sévères eet en cas d'oedème sévere (sur avis médical). Hypersensibilité à un des constituants. PRÉCAUTIONS Atteintes graves nécessitant une immobilisation totale. Appliquer sur peau propre et sèche Ne pas Appliquer en cas de fragilité cutanée ou directament sur un plaie cutanée. Ne jamais Appliquer la bande en tension maximale. En cas d'engourdissements ou de sensations douloureses, ôtez la bande et refaites le bandage moins serré. Si la douleur persiste ou en cas de difficultés, demandez conseil à votre pharmacien, kinésithérapeute ou à votre médecin.

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: FORMASTRAP
UDI-DI code: 08428012301328
Basic UDI-DI: 8428012VF503-201AS
Reference / catalog number: B32003
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: 2.5 MU36
8 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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification