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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

BASIC-SET COMBILIGHT C10/E16… — Class I MDR

MD Atlas
Kirchner & Wilhelm GmbH + Co KG

EUDAMED last updated this device on Nov 3, 2022

BASIC-SET COMBILIGHT C10/E16 ophthalmoscope and otoscope

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: 04030155001535
Reference / catalog number: 02.01104.002

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Manufacturer information

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

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: BASIC-SET COMBILIGHT C10/E16 ophthalmoscope and otoscope
UDI-DI code: 04030155001535
Basic UDI-DI: 4030155KaWe0101YR
Reference / catalog number: 02.01104.002
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: Set of diagnostic instrument for medical examination of the external auditory canal up to the eardrum and diagnostic instrument for optical examination of the fundus of the eye by direct ophthalmoscopy. Basic UDI Ophthalmoscopes: 4030155KaWe0102YT
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
Z12120114OPHTHALMOSCOPES

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

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