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FORLNK™ Manual Retraction Kit - EUDAMED Registration 06952450973950

Access comprehensive regulatory information for FORLNK™ Manual Retraction Kit in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 06952450973950 and manufactured by Shanghai MicroPort EP MedTech Co., Ltd. in China.

This page provides complete registration details including trade name (FORLNK™ Manual Retraction Kit), 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 I
06952450973950
No
FORLNK™ Manual Retraction Kit
Trade Name: FORLNK™ Manual Retraction Kit
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Device Description (EMDN)

CARDIAC TISSUE ABLATION DEVICES - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
C020399
Trade Name
FORLNK™ Manual Retraction Kit
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06952450973950
Basic UDI
69524509C6A10FF
Version Date
July 11, 2024
Manufacturer Last Update
November 15, 2023
Active Status
No
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
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
France
Market Available
Bulgaria:None~None, France:None~None, Germany:None~None, Greece:None~None, Portugal:None~None, Spain:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No