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JADE PTA Balloon Dilatation Catheter - EUDAMED Registration 06934955910166

Access comprehensive regulatory information for JADE PTA Balloon Dilatation Catheter 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 06934955910166 and manufactured by OrbusNeich Medical (Shenzhen) Co.,Ltd in China.

This page provides complete registration details including trade name (JADE PTA), manufacturer information, authorized representative details, competent authority (Health Board, Medical Devices Department), 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
06934955910166
No
JADE PTA Balloon Dilatation Catheter
Trade Name: JADE PTA
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Device Description (EMDN)

PTA BALLOON DILATATION CATHETERS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
C010402020101
Trade Name
JADE PTA
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06934955910166
Basic UDI
B-06934955910166
Version Date
February 11, 2022
Manufacturer Last Update
May 16, 2022
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
1 Jinkui Road People's Republic of China
Email
onra@orbusneich.com
Authorized Representative
SRN
EE-AR-000004308
Country
Estonia
Address
30 Laki tn Tallinn
Email
enquiries@qualityfirstint.com
Telephone
+3726104196
Regulatory Information
Competent Authority
Health Board, Medical Devices Department
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Italy
Market Available
Italy:2020-11-01~None
Device Characteristics
Human Tissues
No
Animal Tissues
No