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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

K02 — Class IIa MDR by PROMETHEUS S.r.l.

MD Atlas
PROMETHEUS S.r.l.

EUDAMED last updated this device on May 28, 2026

K02

805689325TD05.1C9

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PROMETHEUS S.r.l.
UDI-DI code: 08056893250215
Reference / catalog number: K02

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View device family (Basic UDI)

Manufacturer information

Organization name: PROMETHEUS S.r.l.
SRN: IT-MF-000028429
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	May 20, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08056893250215
Basic UDI-DI: 805689325TD05.1C9
Reference / catalog number: K02
Issuing entity: GS1

Classification

Risk category: Class IIa
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

UDI-DI DataMatrix

Encoded

(01)08056893250215

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

B06CELLULAR OR BIOLOGICAL MANIPULATION DEVICES

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.

0425-MDR-030173-00Issued
Quality management systemNotified body: 0425Expiry: Mar 5, 2031