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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

3711 (4002/SG/CS) — Class I MDR by Kaltek S.r.l.

MD Atlas
Kaltek S.r.l.

EUDAMED last updated this device on Mar 23, 2026

3711 (4002/SG/CS)

805551056abbassali_sterSM

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Kaltek S.r.l.
UDI-DI code: 08055510561031
Reference / catalog number: 3711 (4002/SG/CS)

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View device family (Basic UDI)

Manufacturer information

Organization name: Kaltek S.r.l.
SRN: IT-MF-000019573
Manufacturer status: Active

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	Feb 10, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08055510561031
Basic UDI-DI: 805551056abbassali_sterSM
Reference / catalog number: 3711 (4002/SG/CS)
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: https://www.kaltek.it/it/prodotti/sanitari/dispositivi-medici-sanitari/abbassalingua/abbassalingua-sterile
Clinical sizes: 150 MU50
20 MU50
1.6 MU50

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.

V9001TONGUE DEPRESSORS, SINGLE-USE

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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Certificates

Certificate health across this manufacturer's portfolio.

IT348898Issued
Quality management systemNotified body: 1370Expiry: Jan 12, 2030
0425-MDR-030116-00Issued
Quality assuranceNotified body: 0425Expiry: Jan 8, 2030