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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

51743 — Class I MDR by Alisa trgovina in…

MD Atlas
Alisa trgovina in storitve Alenka Stopar s.p.

EUDAMED last updated this device on Jan 30, 2024

51743

383001988984BD

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Alisa trgovina in storitve Alenka Stopar s.p.
UDI-DI code: 03830019881522
Reference / catalog number: 51743

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View device family (Basic UDI)

Manufacturer information

Organization name: Alisa trgovina in storitve Alenka Stopar s.p.
SRN: SI-MF-000014582
Manufacturer status: Active

Related devices

51715383001988982B9On the market 51717383001988982B9On the market 51742383001988984BDOn the market 4934383001988987BKOn the market 4935383001988987BKOn 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

No critical warnings reported for this device.

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Market distribution

Primary placement in Slovenia; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 03830019881522
Basic UDI-DI: 383001988984BD
Reference / catalog number: 51743
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: 1
Additional product description: Lace belt with pocket for stoma
Additional information URL: https://alisalingerie.com/ostomy/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)03830019881522

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

A108099ACCESSORY DEVICES FOR ABDOMINAL OSTOMY - 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

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