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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

4039869012806 — Class IIb MDR by i.com medical GmbH

MD Atlas
i.com medical GmbH

EUDAMED last updated this device on Apr 24, 2024

4039869012806

403986901QE

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: i.com medical GmbH
UDI-DI code: 04039869012806
Reference / catalog number: 4039869012806

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Manufacturer information

Organization name: i.com medical GmbH
SRN: DE-MF-000008660
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Apr 24, 2024	Still on market
Austria	Apr 24, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04039869012806
Basic UDI-DI: 403986901QE
Reference / catalog number: 4039869012806
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Hyaluron Augentropfen
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q0299OPHTHALMIC 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
Expiration date
Manufacturing date
Serial number
Software identification

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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.