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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

KKA197334 — Class I MDR by UNIVET LOUPES SPA

MD Atlas
UNIVET LOUPES SPA

EUDAMED last updated this device on May 19, 2026

KKA197334

8057147TTL013XS

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: UNIVET LOUPES SPA
UDI-DI code: 08057147033417
Reference / catalog number: KKA197334

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View device family (Basic UDI)

Manufacturer information

Organization name: UNIVET LOUPES SPA
SRN: IT-MF-000027104
Manufacturer status: Active

Related devices

KKA195533C8057147TTL013XSOn the market KKA1943348057147TTL013XSOn the market KKA197234C8057147TTL013XSOn the market KKA1981348057147TTL013XSOn the market KKA198334C8057147TTL013XSOn 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 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: 08057147033417
Basic UDI-DI: 8057147TTL013XS
Reference / catalog number: KKA197334
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

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

L0399GENERAL SURGERY INSTRUMENTS, REUSABLE - 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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