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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

Empulse Wheeldrive — Class I MDR by Indes Healthcare BV

MD Atlas
Indes Healthcare BV

EUDAMED last updated this device on Jun 14, 2022

Empulse Wheeldrive

87193275115WHEELDRIVE5H

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Indes Healthcare BV
UDI-DI code: 08719327511534
Reference / catalog number: E1801-1000

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Manufacturer information

Organization name: Indes Healthcare BV
SRN: NL-MF-000000051
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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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: Empulse Wheeldrive
UDI-DI code: 08719327511534
Basic UDI-DI: 87193275115WHEELDRIVE5H
Reference / catalog number: E1801-1000
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: The Empulse Wheeldrive is a relabeled version of the Indes Wheeldrive. The Wheeldrive is a power assist add-on device for manual wheelchairs. Right Wheel.
Additional information URL: https://www.sunrisemedical.eu/e-mobility/e-mpulse/power-assist-wheelchairs/wheeldrive#support
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.

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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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.