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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

55002 — Class I MDR by Integration Diagnostics…

MD Atlas
Integration Diagnostics / NSK Nordic

EUDAMED last updated this device on Apr 30, 2024

55002

735009632PenguinRF

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Integration Diagnostics / NSK Nordic
UDI-DI code: 07350096320012
Reference / catalog number: 55002

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View device family (Basic UDI)

Manufacturer information

Organization name: Integration Diagnostics / NSK Nordic
SRN: SE-MF-000018550
Manufacturer status: Active

Critical warnings

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

CW023
The instrument emits short magnetic pulses with pulse duration of 1 ms and strength of +/- 20 gauss, 10 mm from the instrument tip. Precautions might be necessary when using the instrument close to cardiac pacemakers or other equipment sensitive to magnetic fields.

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Market distribution

Primary placement in Sweden; available across 1 country total.

Country	On market since	Until
SwedenPrimary placement	May 11, 2015	Still on market

Device identification

Trade name: not provided
UDI-DI code: 07350096320012
Basic UDI-DI: 735009632PenguinRF
Reference / catalog number: 55002
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: Device is indicated for use in measuring the stability of dental implants.
Additional information URL: https://penguininstruments.com/
Clinical sizes: 31 MU50
26 MU50
201 MU50

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)07350096320012

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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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Related devices

E1214735009632PenguinRFOn 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.