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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

B435-R250 — Class I MDR by LABORATOIRES COLUXIA

MD Atlas
LABORATOIRES COLUXIA

EUDAMED last updated this device on Jan 19, 2023

B435-R250

37015285PANSEMENTS4Z

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: LABORATOIRES COLUXIA
UDI-DI code: 03701528500009
Reference / catalog number: B435-R250

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Manufacturer information

Organization name: LABORATOIRES COLUXIA
SRN: FR-MF-000009783
Manufacturer status: Active

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: not provided
UDI-DI code: 03701528500009
Basic UDI-DI: 37015285PANSEMENTS4Z
Reference / catalog number: B435-R250
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: Rouleau de 250 pansements prédécoupés en non-tissé blanc enduit de colle médicale acrylique, menés d'une compresse et fournis dans une boite distributrice.
Additional information URL: https://www.coluxia.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M04010101NON-WOVEN ADHESIVE DRESSINGS, WITH ABSORBENT PAD

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

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00200000070037015285SPARADRAPS5YOn the market 00200000020137015285SPARADRAPS5YOn the market

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.