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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

003 — Class I MDR by SANITY HEALTH S.L.U.

MD Atlas
SANITY HEALTH S.L.U.

EUDAMED last updated this device on Oct 25, 2021

003

84365932000396H

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SANITY HEALTH S.L.U.
UDI-DI code: 08436593200039
Reference / catalog number: 003

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Manufacturer information

Organization name: SANITY HEALTH S.L.U.
SRN: ES-MF-000014604
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: 08436593200039
Basic UDI-DI: 84365932000396H
Reference / catalog number: 003
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: MASCARILLA QUIRÚRGICA TIPO IIR
Additional information URL: https://www.sanitycorp.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

R0499RESPIRATORY FILTERS - 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

Related devices

001843659320001563On the market 00284365932000225YOn 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.