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Insulin pen needle - EUDAMED Registration 06957138608964

Access comprehensive regulatory information for Insulin pen needle 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 06957138608964 and manufactured by Tianjin Huahong Technology Co., Ltd. in China.

This page provides complete registration details including 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
06957138608964
No
Insulin pen needle
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
A0101010202
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06957138608964
Basic UDI
69571386PN03WK
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
A01, Plant B, No.278 Hangkong Road Tianjin
Email
huahongsales@163.com
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
Spain
Market Available
Spain:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No