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Pipit NC - EUDAMED Registration 08904118372009

Access comprehensive regulatory information for Pipit NC in the European Union medical device market through Pure Global AI's free database. This Class III device is registered with EU EUDAMED under Primary DI 08904118372009 and manufactured by Sahajanand Medical Technologies Limited in India.

This page provides complete registration details including trade name (Pipit NC), manufacturer information, authorized representative details, competent authority (Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten), 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 III
08904118372009
No
Pipit NC
Trade Name: Pipit NC
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Device Description (EMDN)

PTCA BALLOON DILATION CATHETERS

Device Classification
Risk Class
Class III
CND Nomenclatures Code
C010401020101
Trade Name
Pipit NC
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08904118372009
Basic UDI
B-08904118372009
Version Date
September 28, 2023
Manufacturer Last Update
November 16, 2021
Active Status
No
Manufacturer
Country
India
Country Type
NON_EU
Address
โ€œSahajanand Estateโ€, Wakhariawadi, Surat
Email
eudamed.in@smt.in
Authorized Representative
SRN
BE-AR-000000106
Country
Belgium
Address
53 Boulevard Gรฉnรฉral Wahis Brussels
Email
regulatory@obelis.net
Telephone
+32(2)73 25 954
Regulatory Information
Competent Authority
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Croatia
Market Available
Croatia:2018-01-01~None, Estonia:2018-01-01~None, Hungary:2019-01-01~None, Italy:2020-01-01~None, Romania:2019-01-01~None, Turkey:2018-01-01~None
Device Characteristics
Human Tissues
No
Animal Tissues
No