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Needle driver,Large Needle Driver,Micro Needle Driver  - EUDAMED Registration 06971621541002

Access comprehensive regulatory information for Needle driver,Large Needle Driver,Micro Needle Driver  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 06971621541002 and manufactured by Shanghai MicroPort MedBot (Group) Co., Ltd. in China.

This page provides complete registration details including trade name (Toumai), 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 IIa
06971621541002
No
Needle driver,Large Needle Driver,Micro Needle Driver 
Trade Name: Toumai
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Device Description (EMDN)

ROBOTIC SURGERY INSTRUMENTS, REUSABLE - OTHER

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
L1399
Trade Name
Toumai
Implantable
No
Reusable
Yes
Measuring Function
No
Registration Information
Primary DI
06971621541002
Basic UDI
6971621543J0026C2XN
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
Room 101, Zone B, Building 1, No. 1601, Zhangdong Road, China (Shanghai) Pilot Free Trade Zone Shanghai
Email
MB_customer@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
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Italy
Market Available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No