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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

61100 — IVDR Class A IVDR by nal von minden GmbH

MD Atlas
nal von minden GmbH

EUDAMED last updated this device on Feb 12, 2025

61100

4065384RSS36N1Y3

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: nal von minden GmbH
UDI-DI code: 04065384000158
Reference / catalog number: 61100

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Manufacturer information

Organization name: nal von minden GmbH
SRN: DE-MF-000013321
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 04065384000158
Basic UDI-DI: 4065384RSS36N1Y3
Reference / catalog number: 61100
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: The product is an accessory for digital recording and semi-automatic eva-luation of suitable lateral flow tests in various formats (e.g. test strips, test cassettes). The suitability of the lateral flow tests and the individual evaluation are determined by the test kit used and are the responsibility of the manufacturer or distributor of the test kits. The system serves as an aid for the digitization and interpretation of lateral flow tests
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0201020201IMMUNOCHEMISTRY READERS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.