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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

05 — Class I MDR by ORMESA S.r.l.

MD Atlas
ORMESA S.r.l.

EUDAMED last updated this device on Jul 24, 2025

05

0805571570BIKOX4

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ORMESA S.r.l.
UDI-DI code: 08055715708651
Reference / catalog number: 05

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Manufacturer information

Organization name: ORMESA S.r.l.
SRN: IT-MF-000034824
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW030
The device must be prescribed and / or configured and adjusted by a rehabilitation professional according to the laws in the user's place of residence

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Market distribution

Primary placement in Italy; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08055715708651
Basic UDI-DI: 0805571570BIKOX4
Reference / catalog number: 05
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: https://www.ormesa.com/
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.

Y121806PEDAL TRICYCLES

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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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.