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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

PAL1397.49 — Class I MDR by Ippi srl

MD Atlas
Ippi srl

EUDAMED last updated this device on Oct 10, 2023

PAL1397.49

805475103OLVLE

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ippi srl
UDI-DI code: 08054751030016
Reference / catalog number: PAL1397.49

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View device family (Basic UDI)

Manufacturer information

Organization name: Ippi srl
SRN: IT-MF-000035443
Manufacturer status: Active

Related devices

PAL943.50805475103OLVLEOn the market PAL1648.47805475103OLVLEOn the market PAL852.50805475103OLVLEOn the market PAL928.50805475103OLVLEOn the market PAL1570805475103OLVLEOn 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.

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in France; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08054751030016
Basic UDI-DI: 805475103OLVLE
Reference / catalog number: PAL1397.49
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: OLV VISIC8 + TRAY MD GUIDE
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)08054751030016

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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.

Q0199ODONTOLOGY DEVICES - OTHER

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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