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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

22502 MONO BASICO NO-IMP DE… — Class I MDR by SUMINISTROS…

MD Atlas
SUMINISTROS HOSPITALARIOS S.A.

EUDAMED last updated this device on May 26, 2024

22502 MONO BASICO NO-IMP DE T.S.T. 40GR. VERDE TALLA XL

8426134TSTNE6E

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SUMINISTROS HOSPITALARIOS S.A.
UDI-DI code: 18426134225024
Reference / catalog number: 22502 MONO BASICO NO-IMP DE T.S.T. 40GR. VERDE TALLA XL

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Manufacturer information

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

Related devices

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Critical warnings

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

CW011
EUDAMED did not publish a description for this code.
CW020
EUDAMED did not publish a description for this code.
CW009
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: 18426134225024
Basic UDI-DI: 8426134TSTNE6E
Reference / catalog number: 22502 MONO BASICO NO-IMP DE T.S.T. 40GR. VERDE TALLA XL
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: 50
Additional product description: A two-piece, non-sterile garment designed for use by healthcare personnel to provide the usual hygienic conditions of the surgical site. It usually consists of a shirt and pants made of disposable materials and provides a barrier to help prevent cross-contamination of infectious agents between staff and patients. It is a single-use garment
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
Manufacturing date
Serial number
Software identification

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.