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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

03830078860025 — Class I MDR by RTS Medical, medicinski…

MD Atlas
RTS Medical, medicinski pripomočki, d.o.o.

EUDAMED last updated this device on May 22, 2026

03830078860025

383007886SPEED3XRSPF

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: RTS Medical, medicinski pripomočki, d.o.o.
UDI-DI code: 03830078860025
Reference / catalog number: 03830078860025

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View device family (Basic UDI)

Manufacturer information

Organization name: RTS Medical, medicinski pripomočki, d.o.o.
SRN: SI-MF-000004223
Manufacturer status: Active

Related devices

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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.

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Slovenia; available across 1 country total.

Country	On market since	Until
SloveniaPrimary placement	Feb 1, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 03830078860025
Basic UDI-DI: 383007886SPEED3XRSPF
Reference / catalog number: 03830078860025
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: ELEKTRIČNI POGON Z VLEČENJEM ZA INVALIDSKI VOZIČEK NA ROČNI POGON
Additional information URL: https://speed3x.eu/wp-content/uploads/SPEED3X_RS_USER_MANUAL.pdf
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)03830078860025

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

Y122410ELECTRIC PROPULSION UNIT

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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