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Sterile X-Ray Detectable Lap Sponges - EUDAMED Registration 06936662609814

Access comprehensive regulatory information for Sterile X-Ray Detectable Lap Sponges 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 06936662609814 and manufactured by Kingstar Medical (Xianning) Co., LTD in China.

This page provides complete registration details including trade name (Sterile X-Ray Detectable Lap Sponges ), manufacturer information, authorized representative details, competent authority (DE/CA05 - Behorde fur Justiz und Verbraucherschutz), 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
06936662609814
No
Sterile X-Ray Detectable Lap Sponges
Trade Name: Sterile X-Ray Detectable Lap Sponges
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Device Description (EMDN)

LAPAROTOMY COTTON GAUZES, WITH X-RAY DETECTABLE THREAD, STERILE

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
M0201030201
Trade Name
Sterile X-Ray Detectable Lap Sponges
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06936662609814
Basic UDI
6971872201021011L4
Version Date
February 08, 2025
Manufacturer Last Update
July 17, 2022
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
No. 79 Yong'andong Road Xianning
Email
fan.rong@kingstarmedical.cn
Authorized Representative
SRN
DE-AR-000000001
Country
Germany
Address
80 EiffestraรŸe Hamburg
Email
shholding@hotmail.com
Telephone
+49 40 2513175
Regulatory Information
Competent Authority
DE/CA05 - Behorde fur Justiz und Verbraucherschutz
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
Germany:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No