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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

28688 - 800160 — Class I MDR by Tecnoclínic SA

MD Atlas
Tecnoclínic SA

EUDAMED last updated this device on Dec 18, 2024

28688 - 800160

843657368BCONSTNG

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Tecnoclínic SA
UDI-DI code: 08436573680691
Reference / catalog number: 28688 - 800160

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Manufacturer information

Organization name: Tecnoclínic SA
SRN: ES-MF-000000632
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW999
- Non destinato alla misura e alle prove di laboratorio. - La sacca deve essere collocata in basso, nell'apposito sostegno in posizione verticale e con il tubo di adduzione rivolto verso l'alto. - Durante l'utilizzo evitare piegature o schiacciamenti della sacca e del tubo. - Per i modelli forniti di rubinetto di scarico, verificare la chiusura prima del'utilitzo.

Market distribution

Primary placement in Italy; available across 1 country total.

Placed on the market in Italy; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 08436573680691
Basic UDI-DI: 843657368BCONSTNG
Reference / catalog number: 28688 - 800160
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: 250
Additional product description: Sacche urina 2L
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

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On the market

Certificates

Certificate health across this manufacturer's portfolio.

CGP000124Issued
Quality assuranceNotified body: 0373Expiry: Apr 15, 2029