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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

300189 — Class I MDR by Sense Trading B.V.

MD Atlas
Sense Trading B.V.

EUDAMED last updated this device on Sep 25, 2025

300189

11479871AH

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sense Trading B.V.
UDI-DI code: 08720892690630
Reference / catalog number: 300189

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View device family (Basic UDI)

Manufacturer information

Organization name: Sense Trading B.V.
SRN: NL-MF-000046374
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: not provided
UDI-DI code: 08720892690630
Basic UDI-DI: 11479871AH
Reference / catalog number: 300189
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: Een kunststof bril met aan één zijde een rond kijkgat, voorzien van een katoenen band met daarop klittenband voor bevestiging op het hoofd. Het product wordt gebruikt om één oog af te dekken tijdens oogmetingen (visustesten).
Additional information URL: No additional information URL provided by the manufacturer.
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)08720892690630

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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.

Z1212012099INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - 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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Related devices

30014411479871AHOn 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.