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Introducer Set - EUDAMED Registration 18904224930435

Access comprehensive regulatory information for Introducer Set 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 18904224930435 and manufactured by Meril Life Sciences Pvt. Ltd. in India.

This page provides complete registration details including trade name (Python 2โ„ข), 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 IIa
18904224930435
No
Introducer Set
Trade Name: Python 2โ„ข
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Device Description (EMDN)

CARDIOVASCULAR INTRODUCER SHEATHS, VALVED

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
C0502
Trade Name
Python 2โ„ข
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
18904224930435
Basic UDI
B-18904224930435
Version Date
June 16, 2023
Manufacturer Last Update
June 25, 2021
Active Status
No
Manufacturer
Country
India
Country Type
NON_EU
Address
Muktanand Marg, Chala, Vapi Vapi
Email
askinfo@merillfe.com
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
Germany
Market Available
Germany:2020-03-04~2024-05-26, Greece:2020-03-04~2024-05-26, Turkey:2020-03-04~2024-05-26
Device Characteristics
Human Tissues
No
Animal Tissues
No