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Intraoperative PU Probe Cover - EUDAMED Registration 06975424196490

Access comprehensive regulatory information for Intraoperative PU Probe Cover 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 06975424196490 and manufactured by Exact Medical Manufacturing, Inc 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 IIa
06975424196490
No
Intraoperative PU Probe Cover
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
T030102
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06975424196490
Basic UDI
697542419EC49JB
Version Date
March 10, 2025
Manufacturer Last Update
March 11, 2022
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
21 Qingjiang Road Changzhou
Email
info@exactmm.com
Authorized Representative
SRN
NL-AR-000000452
Country
Netherlands
Address
35 Kerkstraat Nieuwkuijk
Email
cs-eu@exactmm.com
Telephone
+31737600675
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Netherlands
Market Available
Netherlands:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No