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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

ES0005011 — Class I MDR by Laboratorios URGO S.L.

MD Atlas
Laboratorios URGO S.L.

EUDAMED last updated this device on Mar 16, 2026

ES0005011

8413647EXTRAFUERTEFL

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Laboratorios URGO S.L.
UDI-DI code: 08413647050116
Reference / catalog number: ES0005011

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Manufacturer information

Organization name: Laboratorios URGO S.L.
SRN: ES-MF-000000629
Manufacturer status: Active

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Critical warnings

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

CW999
No usar en caso de hipersensibilidad a alguno de los ingredientes
CW999
No usar después de la fecha de caducidad indicada
CW999
Mantener fuera del alcance y de la vista de los niños
CW999
Cerrar el tubo después de cada uso
CW999
Mantener la boca del tubo y el tapón secos

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: 08413647050116
Basic UDI-DI: 8413647EXTRAFUERTEFL
Reference / catalog number: ES0005011
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: Crema adhesiva para prótesis dentales
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

P01020180DENTAL IMPLANTS - ACCESSORIES

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

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.