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WALTZ CoCr Coronary Stent System - EUDAMED Registration 06939963800829

Access comprehensive regulatory information for WALTZ CoCr Coronary Stent System 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 06939963800829 and manufactured by Shanghai MicroPort Medical (Group) Co., Ltd. in China.

This page provides complete registration details including trade name (WaltzTM CoCr Coronary Stent System), 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.

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EUDAMED Official Data
Class III
06939963800829
No
WALTZ CoCr Coronary Stent System
Trade Name: WaltzTM CoCr Coronary Stent System
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Device Description (EMDN)

METALLIC NON-STAINLESS STEEL CORONARY STENTS

Device Classification
Risk Class
Class III
CND Nomenclatures Code
P070402010102
Trade Name
WaltzTM CoCr Coronary Stent System
Implantable
Yes
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06939963800829
Basic UDI
B-06939963800829
Version Date
July 07, 2023
Manufacturer Last Update
February 06, 2023
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
1601 Zhangdong Road Shanghai
Email
customerservice@microport.com
Authorized Representative
SRN
NL-AR-000000166
Country
Netherlands
Address
25 Paasheuvelweg Amsterdam
Email
cs@microport-int.com
Telephone
+31205450100ext8
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Spain
Market Available
Spain:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No