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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

22187 CALZONCILLO UNISEX DE… — Class I MDR by SUMINISTROS…

MD Atlas
SUMINISTROS HOSPITALARIOS S.A.

EUDAMED last updated this device on May 26, 2024

22187 CALZONCILLO UNISEX DE T.S.T. 35GR. COLOR BLANCO

8426134TSTNE6E

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SUMINISTROS HOSPITALARIOS S.A.
UDI-DI code: 18426134221873
Reference / catalog number: 22187 CALZONCILLO UNISEX DE T.S.T. 35GR. COLOR BLANCO

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Manufacturer information

Organization name: SUMINISTROS HOSPITALARIOS S.A.
SRN: ES-MF-000000648
Manufacturer status: Active

Related devices

220168426134TSTNE6EOn the market 22019 BATA DE T.S.T 14GR. CON PUÑO ELÁSTICO VERDE OSCURO8426134TSTNE6EOn the market 22026 BATA DE T.S.T. 25GR. CON PUÑO ELÁSTICO VERDE CLARO8426134TSTNE6EOn the market 22021 CUBREZAPATO DE T.S.T. 30GR. COLOR BLANCO8426134TSTNE6EOn the market 22032 CALZA DE PLÁSTICO 0,018MM COLOR VERDE8426134TSTNE6EOn 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.

Critical warnings

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

CW011
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW020
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW999
En caso de incidente contactar con el Fabricante y Autoridad competente

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: 18426134221873
Basic UDI-DI: 8426134TSTNE6E
Reference / catalog number: 22187 CALZONCILLO UNISEX DE T.S.T. 35GR. COLOR BLANCO
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: 200
Additional product description: Underwear garment to retain urine leakage in incontinent adults and older children. It consists of briefs or panties with the softness and external shape of normal underwear and an insulated pad or wrap capable of retaining urine in patients with light to medium urinary incontinence, keeping the skin dry. It is used in healthcare facilities or at home.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T0299PROTECTION DRAPES AND GARMENTS - OTHER

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
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Software identification