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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

000 08563 000 000 — Class IIb MDD by Tecnilatex, S.A.U.

MD Atlas
Tecnilatex, S.A.U.

EUDAMED last updated this device on Jan 19, 2024

000 08563 000 000

B-08411134138040

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Tecnilatex, S.A.U.
UDI-DI code: 08411134138040
Reference / catalog number: 000 08563 000 000

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Manufacturer information

Organization name: Tecnilatex, S.A.U.
SRN: ES-MF-000000284
Manufacturer status: Active

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW011
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement	Dec 31, 2009	May 25, 2024
Italy	Dec 31, 2009	May 25, 2024

Device identification

Trade name: not provided
UDI-DI code: 08411134138040
Basic UDI-DI: B-08411134138040
Reference / catalog number: 000 08563 000 000
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: CONTROL FINNISIMO ORIGINAL
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

U110101CONDOMS

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

This device is not currently linked to any other device.

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.