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Organization name
UDI-DI code
Reference / catalog number

DORA NITRILE GLOVES VIOLET L — Class I MDR by Vik Dental d.o.o.

MD Atlas
Vik Dental d.o.o.

EUDAMED last updated this device on Mar 30, 2023

DORA NITRILE GLOVES VIOLET L

385989147510006Z7

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Vik Dental d.o.o.
UDI-DI code: 03859891475698
Reference / catalog number: 10006

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Manufacturer information

Organization name: Vik Dental d.o.o.
SRN: HR-MF-000033824
Manufacturer status: Active

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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.
CW011
This product is not made from natural rubber latex. After use, wearers should visually check the gloves and remove any contamination from the outer surface before removing the gloves from the hands. Alternatively, carefully peel the gloves off the hands so that the contaminated outer sides of gloves do not touch the skin.

Market distribution

Primary placement in Croatia; available across 1 country total.

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

Device identification

Trade name: DORA NITRILE GLOVES VIOLET L
UDI-DI code: 03859891475698
Basic UDI-DI: 385989147510006Z7
Reference / catalog number: 10006
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: 200
Additional product description: Nitrile Examination Gloves violet
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T01020204NITRILE 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

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Software identification