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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

765818 — Class I MDR by Mondomed NV

MD Atlas
Mondomed NV

EUDAMED last updated this device on May 26, 2026

765818

542502543fractomedS4

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Mondomed NV
UDI-DI code: 05425025438105
Reference / catalog number: 765818

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View device family (Basic UDI)

Manufacturer information

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

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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.

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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: 05425025438105
Basic UDI-DI: 542502543fractomedS4
Reference / catalog number: 765818
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 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

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