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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

9002-00003 — Class I MDR by EWAC Medical

MD Atlas
EWAC Medical

EUDAMED last updated this device on Aug 15, 2025

9002-00003

87202996139UBC8

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: EWAC Medical
UDI-DI code: 08720299613911
Reference / catalog number: 9002-00003

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View device family (Basic UDI)

Manufacturer information

Organization name: EWAC Medical
SRN: NL-MF-000013185
Manufacturer status: Active

Related devices

9001-600XX87202996139MPCCOn the market 9001-0XXXX87202996139MFBQOn the market 9002-0003787202996139MUCNOn the market 9001-7002887202996139USDAOn 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.

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: 08720299613911
Basic UDI-DI: 87202996139UBC8
Reference / catalog number: 9002-00003
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: Special bicycle for the use in swimming pools. This model is designed for rehabilitation and when peddling in a low tempo hardly any resistance is noticed. However, the faster the peddling the more resistance is experienced.
Additional information URL: https://www.ewacmedical.com/products/underwater-bicycle/
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)08720299613911

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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.

Y121899CYCLES - OTHER

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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