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Organization name
UDI-DI code
Reference / catalog number

795.300.28 — Class IIa MDR by Mytronic GmbH

MD Atlas
Mytronic GmbH

EUDAMED last updated this device on Jun 30, 2024

795.300.28

++D95118023JD

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Mytronic GmbH
UDI-DI code: +D9511802302040
Reference / catalog number: 795.300.28

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Manufacturer information

Organization name: Mytronic GmbH
SRN: DE-MF-000013849
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.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: +D9511802302040
Basic UDI-DI: ++D95118023JD
Reference / catalog number: 795.300.28
Issuing entity: HIBCC

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: MC 3FP-S Spritzekopf (abgewinkelt)
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q01010199DENTAL RESTORATION 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

UDI-PI traceability

Batch number
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Manufacturing date
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Software identification