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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

RPI-Check 1L — IVDR Class A IVDR by RR Mechatronics…

MD Atlas
RR Mechatronics Manufacturing BV

EUDAMED last updated this device on Aug 26, 2025

RPI-Check 1L

8719189137SJ3ZFHS2

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: RR Mechatronics Manufacturing BV
UDI-DI code: 08719189137477
Reference / catalog number: A0016912

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View device family (Basic UDI)

Manufacturer information

Organization name: RR Mechatronics Manufacturing BV
SRN: NL-MF-000023105
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: RPI-Check 1L
UDI-DI code: 08719189137477
Basic UDI-DI: 8719189137SJ3ZFHS2
Reference / catalog number: A0016912
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: RPI-Check is an isotonic solution that is used in the daily routine to monitor the operation of the measurement functions within the RPI. If a shift in performance is determined, it may indicate the RPI requires service.
Additional information URL: https://www.rrmechatronics.com/
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)08719189137477

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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.

W01030199HAEMATOLOGY REAGENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

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.