Pure Global

Urine Collection Bags - EUDAMED Registration 06935491701386

Access comprehensive regulatory information for Urine Collection Bags 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 06935491701386 and manufactured by Jiangsu Kanghua Medical Equipment Co., Ltd. in China.

This page provides complete registration details including trade name (PMH), 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 I
06935491701386
No
Urine Collection Bags
Trade Name: PMH
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Device Description (EMDN)

URINE COLLECTION BAGS

Device Classification
Risk Class
Class I
CND Nomenclatures Code
A06030301
Trade Name
PMH
Implantable
No
Reusable
No
Measuring Function
Yes
Registration Information
Primary DI
06935491701386
Basic UDI
693549170500K3
Version Date
March 04, 2025
Manufacturer Last Update
March 01, 2023
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
Sanhekou Changzhou
Email
kanghua@chinakang-hua.com
Authorized Representative
SRN
DE-AR-000000001
Country
Germany
Address
80 Eiffestraße 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
Portugal
Device Characteristics
Human Tissues
No
Animal Tissues
No