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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

2012 105 — Class I MDR by VOE , S.A

MD Atlas
VOE , S.A

EUDAMED last updated this device on Jan 14, 2025

2012 105

84353533BREASTM2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: VOE , S.A
UDI-DI code: 08435353309081
Reference / catalog number: 2012 105

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Manufacturer information

Organization name: VOE , S.A
SRN: ES-MF-000013290
Manufacturer status: Active

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1002 L84353533FACIALFFOn the market 1002 M84353533FACIALFFOn the market 1002 S84353533FACIALFFOn the market 1002 T84353533FACIALFFOn the market 1003 L84353533FACIALFFOn 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.

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: 2012 105
UDI-DI code: 08435353309081
Basic UDI-DI: 84353533BREASTM2
Reference / catalog number: 2012 105
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: SIZE 105
Additional information URL: No additional information URL provided by the manufacturer.
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

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Expiration date
Manufacturing date
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Software identification