MDI Spacer, Silicone mask, 220 ml, adult
- Risk class
- Class I
- CND nomenclatures code
- R03010301
- Trade name
- SOFT-SIL Silicone Mask, Size: XL
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 04716770868530
- Basic UDI
- 4716770MD03800DU
- Version date
- February 08, 2025
- Manufacturer last update
- May 23, 2024
- Active status
- No
- Manufacturer name
- Besmed Health Business Corp.
- Country
- Taiwan
- Country type
- NON_EU
- Address
- 5 Lane 116, Wu-Kong 2nd Rd, Wu-Ku District New Taipei City
- info@besmed.com
- SRN
- NL-AR-000037688
- Country
- Netherlands
- Address
- 2b Lange Viestraat Utrecht
- eurep@casusconsulting.com
- 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
- Human tissues
- No
- Animal tissues
- No
AEROSOL THERAPY MASKS
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.