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EUDAMED registration 04996404613068No

TOP Endoscopic Hood

TOP CorporationClass IIaEU EUDAMEDTrade name: TOP Endoscopic Hood SHF-045
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIa
CND nomenclatures code
G030899
Trade name
TOP Endoscopic Hood SHF-045
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
04996404613068
Basic UDI
B-04996404613068
Version date
December 25, 2024
Manufacturer last update
May 23, 2024
Active status
No
Manufacturer
Manufacturer name
TOP Corporation
Country
Japan
Country type
NON_EU
Address
19-10 Senju Nakai-cho Adachi-ku, Tokyo
Email
boueki@top-tokyo.co.jp
Authorized representative
Name
MPS Medical Product Service GmbH
SRN
DE-AR-000005009
Country
Germany
Address
20 Borngasse Braunfels
Email
g.froemel@mps-gmbh.eu
Telephone
+49 6442962073
Regulatory information
Competent authority
DE/CA36 - Regierungspräsidium Gießen Abteilung II_Dezernat 25.1 - Arbeitsschutz Gießen I
Applicable legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed on the market
Germany
Market available
France:None~None, Germany:None~None, Italy:None~None, Spain:None~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER

About this record

Access comprehensive regulatory information for TOP Endoscopic Hood 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 04996404613068 and manufactured by TOP Corporation in Japan.

This page provides complete registration details including trade name (TOP Endoscopic Hood SHF-045), manufacturer information, authorized representative details, competent authority (DE/CA36 - Regierungspräsidium Gießen Abteilung II_Dezernat 25.1 - Arbeitsschutz Gießen I), 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.