Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Otoscope head, only, night to… — Class I MDR

MD Atlas
Kirchner & Wilhelm GmbH + Co KG

EUDAMED last updated this device on Nov 7, 2022

Otoscope head, only, night to PICCOLIGHT F.O. LED high

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: 04030155013316
Reference / catalog number: 01.73550.021

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

BASIC-SET COMBILIGHT C10 otoscope4030155KaWe0101YROn the market BASIC-SET COMBILIGHT C10/E10 ophthalmoscope and otoscope4030155KaWe0101YROn the market BASIC-SET COMBILIGHT C10/E15 ophthalmoscope and otoscope4030155KaWe0101YROn the market BASIC-SET COMBILIGHT C10/E16 ophthalmoscope and otoscope4030155KaWe0101YROn the market COMBILIGHT C10 otoscope with plastic head, 2.5 V4030155KaWe0101YROn the market

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: Otoscope head, only, night to PICCOLIGHT F.O. LED high
UDI-DI code: 04030155013316
Basic UDI-DI: 4030155KaWe0101YR
Reference / catalog number: 01.73550.021
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