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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

1012 XXL — Class I MDR by VOE , S.A

MD Atlas
VOE , S.A

EUDAMED last updated this device on Dec 3, 2024

1012 XXL

84353533BREASTM2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: VOE , S.A
UDI-DI code: 08435353339958
Reference / catalog number: 1012 XXL

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Manufacturer information

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

Related devices

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: 1012 XXL
UDI-DI code: 08435353339958
Basic UDI-DI: 84353533BREASTM2
Reference / catalog number: 1012 XXL
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 XXL
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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification