Pure Global

OTOPORT LITE TE + ABR - EUDAMED Registration 05060396170010

Access comprehensive regulatory information for OTOPORT LITE TE + ABR in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 05060396170010 and manufactured by OTODYNAMICS LTD in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (Otodynamics), manufacturer information, authorized representative details, competent authority (DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
Class IIa
05060396170010
Yes
OTOPORT LITE TE + ABR
Trade Name: Otodynamics
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

EVOKED POTENTIAL AUDIOMETRY EQUIPMENTS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Z12140302
Trade Name
Otodynamics
Implantable
No
Reusable
No
Measuring Function
Yes
Registration Information
Primary DI
05060396170010
Basic UDI
B-05060396170010
Version Date
March 23, 2022
Manufacturer Last Update
January 13, 2022
Active Status
Yes
Manufacturer
Manufacturer Name
OTODYNAMICS LTD
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
30-38 Beaconsfield Road Hatfield
Email
support@otodynamics.com
Authorized Representative
SRN
DE-AR-000005430
Country
Germany
Address
41 Schiffgraben Hannover
Email
info@mdssar.com
Regulatory Information
Competent Authority
DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Germany
Market Available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czech Republic:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Turkey:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No