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OTOSCOPE SET - EUDAMED Registration 89640040179570

Access comprehensive regulatory information for OTOSCOPE SET in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 89640040179570 and manufactured by METECH INTERNATIONAL in Pakistan.

This page provides complete registration details including trade name (OTOSCOPE SET), manufacturer information, authorized representative details, competent authority (Nemzeti Népegészségügyi és Gyógyszerészeti Központ ), 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.

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EUDAMED Official Data
Class I
89640040179570
No
OTOSCOPE SET
Trade Name: OTOSCOPE SET
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Device Description (EMDN)

MIDDLE EAR OTOSCOPES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z12021007
Trade Name
OTOSCOPE SET
Implantable
No
Reusable
Yes
Measuring Function
No
Registration Information
Primary DI
89640040179570
Basic UDI
8964004017OTOSCO.1DH
Version Date
July 15, 2024
Manufacturer Last Update
April 11, 2024
Active Status
No
Manufacturer
Manufacturer Name
METECH INTERNATIONAL
Country
Pakistan
Country Type
NON_EU
Address
Muslim Street P.O Taj Pura Mubarik Pura, Sialkot
Email
metechintl1@gmail.com
Authorized Representative
SRN
HU-AR-000034102
Country
Hungary
Address
13. al. 1 Budapest, Auróra utca BUDAPEST
Email
eudamed.representative@gmail.com
Telephone
+36706790786
Regulatory Information
Competent Authority
Nemzeti Népegészségügyi és Gyógyszerészeti Központ
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Spain
Market Available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia: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, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No