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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

4051 1804 — Class I MDR by FARMABAN s.a.

MD Atlas
FARMABAN s.a.

EUDAMED last updated this device on Nov 22, 2024

4051 1804

8428012COMPRESIONTCUJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: FARMABAN s.a.
UDI-DI code: 08428012302493
Reference / catalog number: 4051 1804

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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

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

CW010
EUDAMED did not publish a description for this code.
CW083
EUDAMED did not publish a description for this code.
CW999
Contra-indications • Do not apply directly on open wounds or breached skin. • Decompensated heart insufficiency • Septic phlebitis • Advanced diabetic microangiopathy • Phlegmasia cerulea dolens • Severe arterial occlusive disease in patients with an ankle-brachial pressure index (ABPI) of less than 0.8

Market distribution

Primary placement in Netherlands; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08428012302493
Basic UDI-DI: 8428012COMPRESIONTCUJ
Reference / catalog number: 4051 1804
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: 10 MU10
5 MU36

EMDN nomenclature code(s)

M0304010201ELASTIC COMPRESSION BANDAGES, COHESIVE, LOW EXTENSIBILITY (<70%)

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