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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

387-XXXX — Class I MDR by Van Raam Reha Bikes B.V.

MD Atlas
Van Raam Reha Bikes B.V.

EUDAMED last updated this device on May 31, 2023

387-XXXX

8720299493957AM

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Van Raam Reha Bikes B.V.
UDI-DI code: 08720299493957
Reference / catalog number: 387-XXXX

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Manufacturer information

Organization name: Van Raam Reha Bikes B.V.
SRN: NL-MF-000006693
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08720299493957
Basic UDI-DI: 8720299493957AM
Reference / catalog number: 387-XXXX
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: Therapy Tricycle for people with a disability or a limitation
Additional information URL: https://www.vanraam.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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Related devices

388-XXXX8720299493964AJOn the market 391-XXX8720299493988AYOn the market 392-XXX8720299493995AVOn the market 390-XXX8719327508664B6On the market vanRaam87213257600053HOn 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.