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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

100-BG-P — Class I MDR by TEXTIL ELASTICO, S.L.U

MD Atlas
TEXTIL ELASTICO, S.L.U

EUDAMED last updated this device on Jul 18, 2024

100-BG-P

8425693CNORMAL7W

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: TEXTIL ELASTICO, S.L.U
UDI-DI code: 08425693000014
Reference / catalog number: 100-BG-P

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Manufacturer information

Organization name: TEXTIL ELASTICO, S.L.U
SRN: ES-MF-000000381
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

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

CW010
EUDAMED did not publish a description for this code.
CW262
EUDAMED did not publish a description for this code.
CW999
Enfermedad obstructiva arterial periférica en estado avanzado, insuficiencia cardiaca, flebitis séptica.
CW999
Hipersensibilidad o alergia al tejido.

Market distribution

Primary placement in Spain; available across 3 countries total.

Country	On market since	Until
SpainPrimary placement		Still on market
Italy		Still on market
Portugal		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08425693000014
Basic UDI-DI: 8425693CNORMAL7W
Reference / catalog number: 100-BG-P
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: Media larga con sujeción tejido, sin blonda de compresión normal.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M030405COMPRESSION STOCKINGS

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
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Software identification