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OptimAblate™ Cardiac RF Generator - EUDAMED Registration 06952450972786

Access comprehensive regulatory information for OptimAblate™ Cardiac RF Generator in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 06952450972786 and manufactured by Shanghai MicroPort EP MedTech Co., Ltd. in China.

This page provides complete registration details including trade name (OptimAblate™ Cardiac RF Generator), 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 IIb
06952450972786
Yes
OptimAblate™ Cardiac RF Generator
Trade Name: OptimAblate™ Cardiac RF Generator
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Device Description (EMDN)

CARDIAC TISSUE ABLATION DEVICES - OTHER

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
C020399
Trade Name
OptimAblate™ Cardiac RF Generator
Implantable
No
Reusable
Yes
Measuring Function
Yes
Registration Information
Primary DI
06952450972786
Basic UDI
B-06952450972786
Version Date
January 02, 2025
Manufacturer Last Update
November 15, 2023
Active Status
Yes
Manufacturer
Country
China
Country Type
NON_EU
Address
Building 23&26&28, Lane 588 Tianxiong Rd. Shanghai
Email
customerservice@everpace.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
France
Market Available
France:None~None, Germany:None~None, Italy:None~None, Netherlands:None~None, Spain:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No