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Acutec HeadlessCompression Screw - EUDAMED Registration 06943139689552

Access comprehensive regulatory information for Acutec HeadlessCompression Screw 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 06943139689552 and manufactured by Tianjin Zhengtian Medical Instrument Co., Ltd. in China.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (Finnish Medicines Agency, Supervision and licences, Medical Device Unit), 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
06943139689552
No
Acutec HeadlessCompression Screw
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

CANNULATED SCREWS

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
P09120603
Implantable
Yes
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06943139689552
Basic UDI
B-06943139689552
Version Date
February 19, 2025
Manufacturer Last Update
February 12, 2025
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
No.318, Jingyi Road, Airport Economic Zone Tianjin
Email
info@natongroup.com
Authorized Representative
SRN
FI-AR-000046224
Country
Finland
Address
2 Lääkärinkatu Tampere
Email
info@inion.com
Regulatory Information
Competent Authority
Finnish Medicines Agency, Supervision and licences, Medical Device Unit
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Portugal
Market Available
Portugal:None~None, Spain:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No