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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

A0071 — Class I MDD by Tecnoclínic SA

MD Atlas
Tecnoclínic SA

EUDAMED last updated this device on Apr 22, 2022

A0071

B-08436573680127

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Tecnoclínic SA
UDI-DI code: 08436573680127
Reference / catalog number: A0071

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Manufacturer information

Organization name: Tecnoclínic SA
SRN: ES-MF-000000632
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.

Critical warnings

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

CW007
EUDAMED did not publish a description for this code.
CW999
Do not use as measuring device. Product reuse could cause infection risk. The bag should be substituted before reaching the maximum level. The collection bag must always be hanged by a suport, placing it below the urine bladder to avoid reflux. Fix firmly the connector to the prove or penile adaptor. Make sure that drain tap is closed. Be careful not to crush, clamp or collapse the tube while using the product to avoid restricting the flow of urine into the bag.

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: 08436573680127
Basic UDI-DI: B-08436573680127
Reference / catalog number: A0071
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: URINE COLLECTION BAG 2L CLOSED SYSTEM BASIC WITH ANTIREFLUX VALVE, DRAIN VALVE, SAMPLE PORT CONNECTOR AND CALMP - TUBE 100 CM. - 75 UNITS
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A06030301URINE COLLECTION BAGS

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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Software identification