EUDAMED registration 09342395000151YesIntegre Pro Scan Red-Yellow
- Risk class
- Class IIb
- CND nomenclatures code
- Z12011006
- Trade name
- Integre Pro Scan Red-Yellow
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 09342395000151
- Basic UDI
- B-09342395000151
- Version date
- June 09, 2022
- Manufacturer last update
- May 24, 2021
- Active status
- Yes
- Manufacturer name
- Ellex Medical Pty Ltd
- Country
- Australia
- Country type
- NON_EU
- Address
- 3-4 Second Avenue Mawson Lakes
- rpillay@ellex.com
- Name
- ECREP LIMITED
- SRN
- IE-AR-000003995
- Country
- Ireland
- Address
- 5 Fitzwilliam Square East Dublin
- info@ecrep.ie
- Telephone
- +353 89 225 1951
- Competent authority
- Health Products Regulatory Authority, Medical Devices Department
- Applicable legislation
- MDD (Directive 93/42/EEC on Medical Devices)
- Placed on the market
- France
- Market available
- France:2016-02-02~None
- Human tissues
- No
- Animal tissues
- No
DIODE–PUMPED SOLID–STATE (DPSS) SURGICAL LASER
Access comprehensive regulatory information for Integre Pro Scan Red-Yellow 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 09342395000151 and manufactured by Ellex Medical Pty Ltd in Australia.
This page provides complete registration details including trade name (Integre Pro Scan Red-Yellow ), manufacturer information, authorized representative details, competent authority (Health Products Regulatory Authority, Medical Devices Department), 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.