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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

0801 — Class I MDR by Kaltek S.r.l.

MD Atlas
Kaltek S.r.l.

EUDAMED last updated this device on Mar 23, 2026

0801

805551056speculum_ster45

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Kaltek S.r.l.
UDI-DI code: 08055510560980
Reference / catalog number: 0801

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View device family (Basic UDI)

Manufacturer information

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

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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

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 2 countries total.

Country	On market since	Until
ItalyPrimary placement	Feb 22, 2006	Still on market
Cyprus	Jan 19, 2021	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08055510560980
Basic UDI-DI: 805551056speculum_ster45
Reference / catalog number: 0801
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/ginecologia/speculum-vaginali-monouso/speculum-vaginale-monouso-a-vite-laterale
Clinical sizes: 40 MU24
36 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.

U089006VAGINAL SPECULUM, 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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