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Organization name
UDI-DI code
Reference / catalog number

OTNI Luci Nightcap — Class I MDR by OTN Innovations B.V.

MD Atlas
OTN Innovations B.V.

EUDAMED last updated this device on Jun 4, 2024

OTNI Luci Nightcap

8719992794OTNI1769

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: OTN Innovations B.V.
UDI-DI code: 08719992794492
Reference / catalog number: OTNI 25

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View device family (Basic UDI)

Manufacturer information

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

Related devices

OTNI Luci Connector8719992794OTNI1769On the market OTNI Luci Female Part8719992794OTNI1769On the market OTNI Luci Female Set8719992794OTNI1769On the market OTNI Luci Grit plate8719992794OTNI1769On the market OTNI Luci Lip Set8719992794OTNI1769On 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 Netherlands; available across 1 country total.

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

Device identification

Trade name: OTNI Luci Nightcap
UDI-DI code: 08719992794492
Basic UDI-DI: 8719992794OTNI1769
Reference / catalog number: OTNI 25
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 25 LUCI Nightcap is solely intended to protect the male part and surroundings during sleep, bathing, and other activities when the exo-prosthesis has been removed.
Additional information URL: https://otninnovations.com/en/accessoires/
Clinical sizes: Lower limb amputee
0–125 MU29

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08719992794492

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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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