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ROD - EUDAMED Registration 06942674699873

Access comprehensive regulatory information for ROD 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 06942674699873 and manufactured by Shanghai Sanyou Medical Co., Ltd. in China.

This page provides complete registration details including trade name (ZINA), manufacturer information, authorized representative details, competent authority (The Medicines and Healthcare Products Regulatory Agency), 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
06942674699873
No
ROD
Trade Name: ZINA
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Device Description (EMDN)

THORACOLUMBOSACRAL FIXATION SYSTEMS

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
P09070302
Trade Name
ZINA
Implantable
Yes
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06942674699873
Basic UDI
B-06942674699873
Version Date
June 29, 2022
Manufacturer Last Update
May 18, 2021
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
385 Huirong Road Shanghai
Email
ce-service@sanyou-medical.com
Authorized Representative
SRN
XI-AR-000001836
Country
United Kingdom (Northern Ireland only)
Address
Enterprise Hub, NW Business Complex, Derry
Email
AuthRep@CE-marking.eu
Telephone
+44(33)33031126
Regulatory Information
Competent Authority
The Medicines and Healthcare Products Regulatory Agency
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Germany
Market Available
Germany:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No