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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

6000.E — Class I MDR by Fabricados Triton, S.L.

MD Atlas
Fabricados Triton, S.L.

EUDAMED last updated this device on Mar 27, 2025

6000.E

8424591NGVH

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fabricados Triton, S.L.
UDI-DI code: 8424591600043
Reference / catalog number: 6000.E

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Manufacturer information

Organization name: Fabricados Triton, S.L.
SRN: ES-MF-000018967
Manufacturer status: Inactive

Market distribution

Primary placement in Spain; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 8424591600043
Basic UDI-DI: 8424591NGVH
Reference / catalog number: 6000.E
Issuing entity: HIBCC

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: OPTOTIPO E (SNELLEN)
Additional information URL: http://fabricadostriton.com/12-negatoscopios-y-optotipos
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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

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.