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Hydrocolloid blister plaster - EUDAMED Registration 03615370005202

Access comprehensive regulatory information for Hydrocolloid blister plaster 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 03615370005202 and manufactured by Zhejiang Longterm Medical Technology Co., Ltd. in China.

This page provides complete registration details including trade name (PANSEMENTS AMPOULES EXTRรŠMES B12), 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
03615370005202
No
Hydrocolloid blister plaster
Trade Name: PANSEMENTS AMPOULES EXTRรŠMES B12
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Device Description (EMDN)

HYDROCOLLOID DRESSINGS, NON-COMBINED

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
M04040301
Trade Name
PANSEMENTS AMPOULES EXTRรŠMES B12
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
03615370005202
Basic UDI
69263655200057Y
Version Date
February 20, 2025
Manufacturer Last Update
February 27, 2025
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
ShuangShan Road 277,FuXi Street ,Deqing County 313200 Huzhou City,Zhejiang Deqing, Zhejiang
Email
rachel@longterm-health.com
Authorized Representative
SRN
NL-AR-000000121
Country
Netherlands
Address
Koningin Julianaplein 10, 1e Verd The Hague
Email
info@lotusnl.com
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
France
Market Available
France:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No