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EUDAMED registration 06970757208926No

Balloon Dilatation Catheter

Skynor Medical（Shanghai）Co.,LtdClass IIaEU EUDAMEDTrade name: Hydrus
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIa
CND nomenclatures code
C01050299
Trade name
Hydrus
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06970757208926
Basic UDI
B-06970757208926
Version date
September 28, 2023
Manufacturer last update
September 07, 2022
Active status
No
Manufacturer
Manufacturer name
Skynor Medical（Shanghai）Co.,Ltd
Country
China
Country type
NON_EU
Address
908 Ziping Road，Pudong New area Shanghai
Email
ra@skynor.cn
Authorized representative
Name
Kingsmead Service B.V.
SRN
NL-AR-000002066
Country
Netherlands
Address
36 Zonnehof Nootdorp
Email
office@kingsmead-service.com
Telephone
+31(0) 64 6571 005
Regulatory information
Competent authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed on the market
Turkey
Market available
Turkey:None~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER

About this record

Access comprehensive regulatory information for Balloon Dilatation Catheter 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 06970757208926 and manufactured by Skynor Medical（Shanghai）Co.,Ltd in China.

This page provides complete registration details including trade name (Hydrus), 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.