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Silicone foam dressing - EUDAMED Registration 03615370005301

Access comprehensive regulatory information for Silicone foam dressing in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 03615370005301 and manufactured by Zhejiang Longterm Medical Technology Co., Ltd. in China.

This page provides complete registration details including trade name (PANSEMENTS SPร‰CIAUX BRร›LURES B5), 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 IIb
03615370005301
No
Silicone foam dressing
Trade Name: PANSEMENTS SPร‰CIAUX BRร›LURES B5
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Device Description (EMDN)

SILICONE DRESSINGS, NON-COMBINED

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
M04040701
Trade Name
PANSEMENTS SPร‰CIAUX BRร›LURES B5
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
03615370005301
Basic UDI
69263655200137X
Version Date
March 08, 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