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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

22185 CALZA DE PLÁSTICO… — Class I MDR by SUMINISTROS…

MD Atlas
SUMINISTROS HOSPITALARIOS S.A.

EUDAMED last updated this device on May 26, 2024

22185 CALZA DE PLÁSTICO RESISTENTE 0,040MM COLOR AZUL

8426134TSTNE6E

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SUMINISTROS HOSPITALARIOS S.A.
UDI-DI code: 28426134221856
Reference / catalog number: 22185 CALZA DE PLÁSTICO RESISTENTE 0,040MM COLOR AZUL

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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: 28426134221856
Basic UDI-DI: 8426134TSTNE6E
Reference / catalog number: 22185 CALZA DE PLÁSTICO RESISTENTE 0,040MM COLOR AZUL
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: 2000
Additional product description: Non-sterile device made of a non-conductive material (plastic or TST) designed as a physical barrier over a shoe to prevent cross-contamination between the shoe and the environment. It is a single-use device
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T0208SHOE COVERS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)

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