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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

Customized Elbow Support Neoprene S — Class I MDR

MD Atlas
Customized innovations i Sverige AB

EUDAMED last updated this device on Jun 18, 2025

Customized Elbow Support Neoprene S

735012084Elbow015V

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Customized innovations i Sverige AB
UDI-DI code: 07350120844941
Reference / catalog number: CCS2182S

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View device family (Basic UDI)

Manufacturer information

Organization name: Customized innovations i Sverige AB
SRN: SE-MF-000047918
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Sweden; available across 1 country total.

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

Device identification

Trade name: Customized Elbow Support Neoprene S
UDI-DI code: 07350120844941
Basic UDI-DI: 735012084Elbow015V
Reference / catalog number: CCS2182S
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: A neoprene-based elbow support designed to provide compression and targeted support for individuals with elbow strain, overuse injuries, or inflammation. Features an integrated EVA pad and adjustable Velcro strap for customized fit and stabilization during movement.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: S

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)07350120844941

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Y060615ELBOW ORTHOSES

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

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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.