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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

OTNI Offsetplate 40mm — Class I MDR by OTN Innovations B.V.

MD Atlas
OTN Innovations B.V.

EUDAMED last updated this device on Mar 19, 2024

OTNI Offsetplate 40mm

8719992794OTNI1769

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: OTN Innovations B.V.
UDI-DI code: 08719992794447
Reference / catalog number: OTNI 1740

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View device family (Basic UDI)

Manufacturer information

Organization name: OTN Innovations B.V.
SRN: NL-MF-000023058
Manufacturer status: Active

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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 Netherlands; available across 1 country total.

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

Device identification

Trade name: OTNI Offsetplate 40mm
UDI-DI code: 08719992794447
Basic UDI-DI: 8719992794OTNI1769
Reference / catalog number: OTNI 1740
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: The OTNI Offsetplate is a component used to provide correct alignment of the exo-prothesis with respect to the angle of bone anchored implant. The OTNI 1740 provides 40mm offset.
Additional information URL: https://otninnovations.com/product/luci/
Clinical sizes: Lower extremity protheses
0–125 MU29

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08719992794447

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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.

Y062499LOWER EXTREMITY PROSTHESES - 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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