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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

C14 — Class I MDR by ENVASES FARMACÉUTICOS,…

MD Atlas
ENVASES FARMACÉUTICOS, S.A.

EUDAMED last updated this device on May 21, 2026

C14

8431785UDI-DI-016F

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ENVASES FARMACÉUTICOS, S.A.
UDI-DI code: 08430321723678
Reference / catalog number: C14

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Manufacturer information

Organization name: ENVASES FARMACÉUTICOS, S.A.
SRN: ES-MF-000000902
Manufacturer status: Active

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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.

Country	On market since	Until
SpainPrimary placement	Dec 15, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08430321723678
Basic UDI-DI: 8431785UDI-DI-016F
Reference / catalog number: C14
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: Finalidad Para la recogida de orina y/o heces en pacientes encamados o con movilidad reducida. Destinada al uso hospitalario y/o domiciliario. Descripción Orinal en forma de cuña, con paredes bajas, bordes redondeados y asa en forma de “L”, para fácil manejo y transporte. Capacidad: 2000 ml Peso neto: 435 g Altura máxima: 93 mm Largo máximo: 430 mm Ancho máximo: 267 mm Composición Polipropileno copolímero y colorante blanco.
Additional information URL: https://eifu.enfa.es/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V0812FECES AND URINE COLLECTION AIDS (BED PANS AND PARROTS)

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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