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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

1001-E — Class I MDR by TEMAER HOSPITALARIA S.A.

MD Atlas
TEMAER HOSPITALARIA S.A.

EUDAMED last updated this device on Apr 29, 2022

1001-E

84370061000BLSONQ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: TEMAER HOSPITALARIA S.A.
UDI-DI code: 18437006315347
Reference / catalog number: 1001-E

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Manufacturer information

Organization name: TEMAER HOSPITALARIA S.A.
SRN: ES-MF-000014221
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW009
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	Nov 20, 1998	Apr 29, 2022
EL	Dec 12, 2017	Apr 29, 2022

Device identification

Trade name: not provided
UDI-DI code: 18437006315347
Basic UDI-DI: 84370061000BLSONQ
Reference / catalog number: 1001-E
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: The urine bag is a compartiment totally sealed excepting the zone where the urine comes in. This part is equipped with an adhesive with the purpose to fix perfectly the bag to the skins patient to avoid liquids leaks. With this aim an inner anti-regression valve has been designed, when the specimen is in the lower side is not possible to return in the opposite side avoiding specimens leaks and contacts between the urine and patients skins, this prevents skins irritations . Sealed edges are non-atraumatics and his round desing avoid any injure in patients skin. His special wings desing allow to fit the urine bag such as boys or girls .
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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

100984370061000ESPT2On the market 1002-E84370061000BLSONQOn the market VAGINAL ESPECULUM ROSCA TH SMALL SIZE84370061000ESPT2On the market

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.