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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

3D-SHAPER — Class IIa MDR by 3D-Shaper Medical S.L.

MD Atlas
3D-Shaper Medical S.L.

EUDAMED last updated this device on Oct 1, 2025

3D-SHAPER

84370217403DSHAPERGA

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: 3D-Shaper Medical S.L.
UDI-DI code: 08437021740035
Reference / catalog number: 3D-SHAPER ver 2.13

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Manufacturer information

Organization name: 3D-Shaper Medical S.L.
SRN: ES-MF-000001324
Manufacturer status: Active

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Aug 9, 2023	Still on market

Device identification

Trade name: 3D-SHAPER
UDI-DI code: 08437021740035
Basic UDI-DI: 84370217403DSHAPERGA
Reference / catalog number: 3D-SHAPER ver 2.13
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: A stand-alone medical software that provides a 3D analysis of the proximal femur from a hip dual-energy X-ray absorptiometry (DXA) scan
Additional information URL: https://www.3d-shaper.com/en/index.html
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11900182BONE DENSITOMETRY SYSTEMS - SOFTWARE ACCESSORIES

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

Related devices

3D-SHAPER84370217403DSHAPERGAOn the market 3D-SHAPER Ver.2.1484370217403DSHAPERGAOn 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.