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

Lumo Spacer, STD-E — Class I MDR by macu4 GmbH

MD Atlas
macu4 GmbH

EUDAMED last updated this device on Aug 5, 2025

Lumo Spacer, STD-E

426242965P030207RT

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: macu4 GmbH
UDI-DI code: 04262429650686
Reference / catalog number: 4262429650686

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: macu4 GmbH
SRN: DE-MF-000038447
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: Lumo Spacer, STD-E
UDI-DI code: 04262429650686
Basic UDI-DI: 426242965P030207RT
Reference / catalog number: 4262429650686
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y0699EXTERNAL PROSTHESES AND ORTHOSES - 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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

Explorer Ball Module, Small, with Spacer426242965P01BALL2WOn the market Explorer Ball Module, Small, without Spacer426242965P01BALL2WOn the market Explorer Ball Module, Standard, with Spacer426242965P01BALL2WOn the market Explorer Ball Module, Standard, without Spacer426242965P01BALL2WOn the market Explorer Bike Module with Spacer426242965P01BIKE3MOn 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.