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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

EP3 OFF-ROAD — Class I MDR by Pandhora S.r.l.

MD Atlas
Pandhora S.r.l.

EUDAMED last updated this device on May 6, 2022

EP3 OFF-ROAD

8052536060ELECTRICEP3T5

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Pandhora S.r.l.
UDI-DI code: 08052536060043
Reference / catalog number: EP3 OFF-ROAD

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View device family (Basic UDI)

Manufacturer information

Organization name: Pandhora S.r.l.
SRN: IT-MF-000021648
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

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.

Placed on the market in Italy; per-country availability dates not published.

Device identification

Trade name: EP3 OFF-ROAD
UDI-DI code: 08052536060043
Basic UDI-DI: 8052536060ELECTRICEP3T5
Reference / catalog number: EP3 OFF-ROAD
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: https://www.pandhora.it/it/pandhora-ep3/
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)08052536060043

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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.

Y122410ELECTRIC PROPULSION UNIT

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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Related devices

EP3 ENDURO8052536060ELECTRICEP3T5On the market EP3 PLUS8052536060ELECTRICEP3T5On the market EP3 SMART8052536060ELECTRICEP3T5On the market EP3 STANDARD8052536060ELECTRICEP3T5On the market PEVO DOUBLE805253606MANUALWHYBOn 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.