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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

PAK-01 — Class IIa MDR by PROMETHEUS S.r.l.

MD Atlas
PROMETHEUS S.r.l.

EUDAMED last updated this device on May 19, 2025

PAK-01

805689325TD02HL

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PROMETHEUS S.r.l.
UDI-DI code: 08056893250062
Reference / catalog number: PAK-01

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View device family (Basic UDI)

Manufacturer information

Organization name: PROMETHEUS S.r.l.
SRN: IT-MF-000028429
Manufacturer status: Active

Related devices

Ematik Lab Kit805689325TD02HLOn the market ELK-01805689325TD02HLOn the market Partisel805689325TD01HJOn the market PA-01805689325TD01HJOn the market EL-01805689325TD01HJOn the market

Certificates

Certificate health across this manufacturer's portfolio.

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

Critical warnings

5 warnings recorded — scroll inside the panel to see all entries.

CW008
EUDAMED did not publish a description for this code.
CW011
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

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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: 08056893250062
Basic UDI-DI: 805689325TD02HL
Reference / catalog number: PAK-01
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: IFU italiano
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)08056893250062

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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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