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Organization name
UDI-DI code
Reference / catalog number

URINE COLLECTION BOTTLE — Class I MDR by Deltalab, S.L.

MD Atlas
Deltalab, S.L.

EUDAMED last updated this device on May 7, 2026

URINE COLLECTION BOTTLE

84356058UDI-DI-096G

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Deltalab, S.L.
UDI-DI code: 08435263802054
Reference / catalog number: 19591

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Manufacturer information

Organization name: Deltalab, S.L.
SRN: ES-MF-000000153
Manufacturer status: Active

Critical warnings

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

CW010
1. Not suitable for any other application tan its intended use. 2. The use of the pan and bottle presents no difficulty for the intended end users. 3. Do not use the pan or bottle if the package is damaged. 4. It should be cleaned with detergent and disinfected with bleach or other disinfectants, before each use. The pan is suitable for use in disinfectant washers. 5. The life of the pan is determined by wear and deterioration due to use. Discard when colour changes, roughness, de- formations, etc. are detected.

Market distribution

Primary placement in Portugal; available across 2 countries total.

Country	On market since	Until
PortugalPrimary placement	Sep 23, 2020	Still on market
Romania	Oct 4, 2013	Still on market

Device identification

Trade name: URINE COLLECTION BOTTLE
UDI-DI code: 08435263802054
Basic UDI-DI: 84356058UDI-DI-096G
Reference / catalog number: 19591
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: 60
Additional product description: —
Additional information URL: https://www.deltalabgroup.com/eifus
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V0812FECES AND URINE COLLECTION AIDS (BED PANS AND PARROTS)

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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Certificates

Certificate health across this manufacturer's portfolio.

2024 PR 0038Issued
Quality assuranceNotified body: 0318Expiry: Oct 21, 2029