Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners 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

765823 — Class I MDR by Mondomed NV

MD Atlas
Mondomed NV

EUDAMED last updated this device on May 26, 2026

765823

542502543fractomedS4

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Mondomed NV
UDI-DI code: 05425025438792
Reference / catalog number: 765823

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?

View device family (Basic UDI)

Manufacturer information

Organization name: Mondomed NV
SRN: BE-MF-000001283
Manufacturer status: Active

Related devices

Fractomed542502543fractomedS4On the market Fractomed542502543fractomedS4On the market Fractomed542502543fractomedS4On the market Fractomed542502543fractomedS4On the market Fractomed542502543fractomedS4On the market

Certificates

Certificate health across this manufacturer's portfolio.

BE24/00000069Issued
Quality management systemNotified body: 1639Expiry: Mar 8, 2029

Critical warnings

No critical warnings reported for this device.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

Market distribution

Primary placement in Belgium; available across 2 countries total.

Country	On market since	Until
BelgiumPrimary placement		Still on market
Germany		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05425025438792
Basic UDI-DI: 542502543fractomedS4
Reference / catalog number: 765823
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: 5
Additional product description: Unterschenkel-Schiene Spezialwinkel L
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

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

M030504IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES

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

Become a partner of MD Atlas