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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

640012 — Class I MDR by iMED ApS

MD Atlas
iMED ApS

EUDAMED last updated this device on Apr 3, 2025

640012

5745000816TPTPE7N

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: iMED ApS
UDI-DI code: 05745000816002
Reference / catalog number: 640012

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View device family (Basic UDI)

Manufacturer information

Organization name: iMED ApS
SRN: DK-MF-000032070
Manufacturer status: Active

Related devices

19-10005745000816TPTPE7NOn the market iMED Tooth Protector, double5745000816TPTPE7NOn the market ME1266075745000816TPTPE7NOn 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

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

CW011
The device is contraindicated in patients with abnormal oral cavity physiology or any other condition that, in the clinical judgment of the responsible healthcare professional, may pose a risk or contraindicate its use.

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Market distribution

Primary placement in Denmark; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 05745000816002
Basic UDI-DI: 5745000816TPTPE7N
Reference / catalog number: 640012
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: Medical mouthguard intended for use during medical procedures, including intubation. The device is intended exclusively for use by authorised healthcare professionals.
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)05745000816002

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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.

T0306PATIENT PROTECTION DEVICES DURING CLINICAL PROCEDURES

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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