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Organization name
UDI-DI code
Reference / catalog number

SAN-054CBL Black XXL — Class I MDR by SANKOM SA

MD Atlas
SANKOM SA

EUDAMED last updated this device on Apr 25, 2025

SAN-054CBL Black XXL

7640125930710102AH

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SANKOM SA
UDI-DI code: 07640125937787
Reference / catalog number: SAN-054CBL Black XXL

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Manufacturer information

Organization name: SANKOM SA
SRN: CH-MF-000047525
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.

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: 07640125937787
Basic UDI-DI: 7640125930710102AH
Reference / catalog number: SAN-054CBL Black XXL
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: The SANKOM Shaper is the first shaper in the world that does not just highlight figure but also improves health with the use of the special rebalancing effect The diagonal compression of the SANKOM Shaper corrects the spine position, adjusts the center of gravity and returns it into anatomically correct position The SANKOM Shaper distributes the excess weight load strategically and eliminates lower back pain
Additional information URL: https://www.sankom.com/collections/shapewear
Clinical sizes: No clinical sizes registered for this device.

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

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Manufacturing date
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