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MDI Spacer, Silicone mask, 220 ml, adult - EUDAMED Registration 04716770868530

Access comprehensive regulatory information for MDI Spacer, Silicone mask, 220 ml, adult 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 04716770868530 and manufactured by Besmed Health Business Corp. in Taiwan.

This page provides complete registration details including trade name (SOFT-SIL Silicone Mask, Size: XL), 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 I
04716770868530
No
MDI Spacer, Silicone mask, 220 ml, adult
Trade Name: SOFT-SIL Silicone Mask, Size: XL
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Device Description (EMDN)

AEROSOL THERAPY MASKS

Device Classification
Risk Class
Class I
CND Nomenclatures Code
R03010301
Trade Name
SOFT-SIL Silicone Mask, Size: XL
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
04716770868530
Basic UDI
4716770MD03800DU
Version Date
February 08, 2025
Manufacturer Last Update
May 23, 2024
Active Status
No
Manufacturer
Country
Taiwan
Country Type
NON_EU
Address
5 Lane 116, Wu-Kong 2nd Rd, Wu-Ku District New Taipei City
Email
info@besmed.com
Authorized Representative
SRN
NL-AR-000037688
Country
Netherlands
Address
2b Lange Viestraat Utrecht
Email
eurep@casusconsulting.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
Austria
Market Available
Germany:2012-06-14~None, Lithuania:2012-06-14~None, Austria:2012-06-14~None
Device Characteristics
Human Tissues
No
Animal Tissues
No