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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

Starrsed DL 10L — IVDR Class A IVDR by RR Mechatronics…

MD Atlas
RR Mechatronics Manufacturing BV

EUDAMED last updated this device on Aug 29, 2025

Starrsed DL 10L

8719189137C4AZKNFZ

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: 08719189137514
Reference / catalog number: A0022583

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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: Starrsed DL 10L
UDI-DI code: 08719189137514
Basic UDI-DI: 8719189137C4AZKNFZ
Reference / catalog number: A0022583
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: Reagent for the automatic dilution of blood samples in Starrsed ESR analyzers
Additional information URL: https://rrmechatronics.com/documentation/sds-and-package-inserts/
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)08719189137514

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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.

W0103010105CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)

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.