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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

1091012 — Class I MDR by Akzenta International SA

MD Atlas
Akzenta International SA

EUDAMED last updated this device on May 13, 2026

1091012

42504766GLOUP

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Akzenta International SA
UDI-DI code: 04250476607913
Reference / catalog number: 1091012

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Manufacturer information

Organization name: Akzenta International SA
SRN: CH-MF-000036434
Manufacturer status: Active

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GLODL29-AKZ-WH-S0142504766GLOUPOn the market GLODL29-AKZ-WH-M0142504766GLOUPOn the market GLODL29-AKZ-WH-LL142504766GLOUPOn the market GLODL29-AKZ-WH-XS142504766GLOUPOn the market GLODL53-AKZ-WH-S0142504766GLOUPOn 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

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

CW009
EUDAMED did not publish a description for this code.
CW999
This product contains natural rubber latex which may cause allergic reactions, including anaphylactic responses. If allergic reactions occur, seek for medical advice immediately.

Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04250476607913
Basic UDI-DI: 42504766GLOUP
Reference / catalog number: 1091012
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: 100
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: XS

EMDN nomenclature code(s)

T010201LATEX EXAMINATION / TREATMENT GLOVES

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