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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

COMBILIGHT F.O.30 otoscope incl.… — Class I MDR

MD Atlas
Kirchner & Wilhelm GmbH + Co KG

EUDAMED last updated this device on Nov 7, 2022

COMBILIGHT F.O.30 otoscope incl. charg. battery LiIon (C)

4030155KaWe0101YR

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Kirchner & Wilhelm GmbH + Co KG
UDI-DI code: 04030155008084
Reference / catalog number: 01.12430.101

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Manufacturer information

Organization name: Kirchner & Wilhelm GmbH + Co KG
SRN: DE-MF-000006338
Manufacturer status: Active

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Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW147
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: COMBILIGHT F.O.30 otoscope incl. charg. battery LiIon (C)
UDI-DI code: 04030155008084
Basic UDI-DI: 4030155KaWe0101YR
Reference / catalog number: 01.12430.101
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: Diagnostic instrument for medical examination of the external auditory canal up to the eardrum.
Additional information URL: https://www.kawemed.com/download/gebrauchsanweisungen/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12021007MIDDLE EAR OTOSCOPES

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

Certificates

Certificate health across this manufacturer's portfolio.

MDR-002Issued
Quality management systemNotified body: 1304Expiry: Sep 26, 2028