Surgical Foam Kits
- Risk class
- Class I
- CND nomenclatures code
- Z12011299
- Trade name
- Surgical Foam Kits
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 00749756348744
- Basic UDI
- 07497560746KTB9
- Active status
- No
- Manufacturer name
- DeRoyal Industries, Inc.
- Country
- United States
- Country type
- NON_EU
- Address
- 200 DeBusk Ln Powell
- ereed@deroyal.com
- SRN
- NL-AR-000024028
- Country
- Netherlands
- Address
- 33 Prinses Margrietplantsoen The Hague
- EU-AR@medenvoyglobal.com
- Telephone
- +31 70 326 21 48
- Competent authority
- Ministerie van Volksgezondheid, Welzijn en Sport
- Applicable legislation
- MDR (REGULATION (EU) 2017/745 on medical devices)
- Placed on the market
- Netherlands
- Market available
- Austria:2021-06-03~None, Belgium:2021-06-03~None, Bulgaria:2021-06-03~None, Croatia:2021-06-03~None, Cyprus:2021-06-03~None, Czechia:2021-06-03~None, Denmark:2021-06-03~None, Estonia:2021-06-03~None, Finland:2021-06-03~None, France:2021-06-03~None, Germany:2021-06-03~None, Greece:2021-06-03~None, Hungary:2021-06-03~None, Iceland:2021-06-03~None, Ireland:2021-06-03~None, Italy:2021-06-03~None, Latvia:2021-06-03~None, Liechtenstein:2021-06-03~None, Lithuania:2021-06-03~None, Luxembourg:2021-06-03~None, Malta:2021-06-03~None, Netherlands:2021-06-03~None, Norway:2021-06-03~None, Poland:2021-06-03~None, Portugal:2021-06-03~None, Romania:2021-06-03~None, Slovakia:2021-06-03~None, Slovenia:2021-06-03~None, Spain:2021-06-03~None, Sweden:2021-06-03~None, Türkiye:2021-06-03~None, United Kingdom (Northern Ireland only):2021-06-03~None
- Human tissues
- No
- Animal tissues
- No
PATIENT POSITIONING INSTRUMENTS – OTHER
Access comprehensive regulatory information for Surgical Foam Kits 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 00749756348744 and manufactured by DeRoyal Industries, Inc. in United States.
This page provides complete registration details including trade name (Surgical Foam Kits), 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.