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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

C05 — Class I MDR by ENVASES FARMACÉUTICOS,…

MD Atlas
ENVASES FARMACÉUTICOS, S.A.

EUDAMED last updated this device on Apr 20, 2022

C05

8431785UDI-DI-026H

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ENVASES FARMACÉUTICOS, S.A.
UDI-DI code: 08431785003535
Reference / catalog number: C05

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Manufacturer information

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

Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement		Still on market
Portugal		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08431785003535
Basic UDI-DI: 8431785UDI-DI-026H
Reference / catalog number: C05
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 en pacientes encamados o con movilidad reducida. Descripción Forma anatómica con la boca con bordes redondeados. El cuerpo está graduado cada 100 ml, hasta los 1000 ml. Color natural. Fabricado en polietileno de alta densidad (HDPE).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 1000 MU03

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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.