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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

FLH311 — Class I MDR by Ordisi, S.A

MD Atlas
Ordisi, S.A

EUDAMED last updated this device on Oct 25, 2021

FLH311

84352050FLH3L6

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ordisi, S.A
UDI-DI code: 08435205000012
Reference / catalog number: FLH311

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Manufacturer information

Organization name: Ordisi, S.A
SRN: ES-MF-000000987
Manufacturer status: Active

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: 08435205000012
Basic UDI-DI: 84352050FLH3L6
Reference / catalog number: FLH311
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: —
Additional information URL: https://www.ordisi.com/es/p1/lampara-de-examen-35klux-rodable/iluminacion/lamparas-de-examen-serie-flh-3-35klux
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12010702MOBILE SCIALYTIC LAMPS

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.