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Disposable pressure infusor - EUDAMED Registration 06975871860593

Access comprehensive regulatory information for Disposable pressure infusor 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 06975871860593 and manufactured by Ningbo KK-Bioscience Co., Ltd. in China.

This page provides complete registration details including 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
06975871860593
No
Disposable pressure infusor
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

AUTOTRANSFUSION DEVICES - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
B0499
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06975871860593
Basic UDI
697587186DIB001MZ
Version Date
December 16, 2024
Manufacturer Last Update
November 23, 2021
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
38 #38, Dongzhou Industrial Park, Xi`dian Town, Ningbo
Email
sales@kk-bioscience.com
Authorized Representative
SRN
NL-AR-000001490
Country
Netherlands
Address
701 Joop Geesinkweg Amsterdam-Duivendrech
Email
ce-tech@humiss.com
Telephone
+31 (0)20 369 8116
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
Device Characteristics
Human Tissues
No
Animal Tissues
No