Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

3D-SHAPER Ver.2.14 — 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 Ver.2.14

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: 08437021740059
Reference / catalog number: 3D-SHAPER

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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	May 21, 2024	Still on market

Device identification

Trade name: 3D-SHAPER Ver.2.14
UDI-DI code: 08437021740059
Basic UDI-DI: 84370217403DSHAPERGA
Reference / catalog number: 3D-SHAPER
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-SHAPER84370217403DSHAPERGAOn 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.