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EUDAMED registration 08906172230066No

MYOCARDIAL PROTECTION SYSTEM

MEDIHUB SCIENCETEC PRIVATE LIMITEDClass IIaEU EUDAMEDTrade name: SPICTRA
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIa
CND nomenclatures code
C030102
Trade name
SPICTRA
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
08906172230066
Basic UDI
B-08906172230066
Version date
March 25, 2024
Manufacturer last update
June 08, 2021
Active status
No
Manufacturer
Manufacturer name
MEDIHUB SCIENCETEC PRIVATE LIMITED
Country
India
Country type
NON_EU
Address
Plot No 4, NH-7, MMDA Industrial Estate, Maraimalai Nagar Tamil Nadu
Email
enquiry@spictra.com
Authorized representative
Name
Meddevices Lifesciences B.V.
SRN
NL-AR-000000594
Country
Netherlands
Address
Keizersgracht 482 Amsterdam
Email
nk@meddevices.net
Telephone
+31202254558
Regulatory information
Competent authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable legislation
MDD (Directive 93/42/EEC on Medical Devices)
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

CARDIOPLEGIA SOLUTION ADMINISTRATION KITS

About this record

Access comprehensive regulatory information for MYOCARDIAL PROTECTION SYSTEM 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 08906172230066 and manufactured by MEDIHUB SCIENCETEC PRIVATE LIMITED in India.

This page provides complete registration details including trade name (SPICTRA ), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), 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.