EUDAMED registration 00850038669676YesLABS Series Cryostorage Systems
- Risk class
- Class IIa
- CND nomenclatures code
- W020702
- Trade name
- Revolution 613
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 00850038669676
- Basic UDI
- 0850038669003VS
- Version date
- March 22, 2024
- Manufacturer last update
- March 22, 2024
- Active status
- Yes
- Manufacturer name
- IC Biomedical, LLC
- Country
- United States
- Country type
- NON_EU
- Address
- 1031 Cass White Road Cartersville
- dbowers@icbiomedical.com
- SRN
- DE-AR-000005009
- Country
- Germany
- Address
- 20 Borngasse Braunfels
- g.froemel@mps-gmbh.eu
- Telephone
- +49 6442962073
- Competent authority
- DE/CA36 - Regierungspräsidium Gießen Abteilung II_Dezernat 25.1 - Arbeitsschutz Gießen I
- Applicable legislation
- MDR (REGULATION (EU) 2017/745 on medical devices)
- Placed on the market
- Germany
- Market available
- Austria:2024-03-18~None, Belgium:2024-03-18~None, Bulgaria:2024-03-18~None, Croatia:2024-03-18~None, Cyprus:2024-03-18~None, Czechia:2024-03-18~None, Denmark:2024-03-18~None, Estonia:2024-03-18~None, Finland:2024-03-18~None, France:2024-03-18~None, Germany:2024-03-18~None, Greece:2024-03-18~None, Hungary:2024-03-18~None, Iceland:2024-03-18~None, Ireland:2024-03-18~None, Italy:2024-03-18~None, Latvia:2024-03-18~None, Liechtenstein:2024-03-18~None, Lithuania:2024-03-18~None, Luxembourg:2024-03-18~None, Malta:2024-03-18~None, Netherlands:2024-03-18~None, Norway:2024-03-18~None, Poland:2024-03-18~None, Portugal:2024-03-18~None, Romania:2024-03-18~None, Slovakia:2024-03-18~None, Slovenia:2024-03-18~None, Spain:2024-03-18~None, Sweden:2024-03-18~None, Türkiye:2024-03-18~None, United Kingdom (Northern Ireland only):2024-03-18~None
- Human tissues
- No
- Animal tissues
- No
CRYOGENICS / FROZEN
Access comprehensive regulatory information for LABS Series Cryostorage Systems in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 00850038669676 and manufactured by IC Biomedical, LLC in United States.
This page provides complete registration details including trade name (Revolution 613), manufacturer information, authorized representative details, competent authority (DE/CA36 - Regierungspräsidium Gießen Abteilung II_Dezernat 25.1 - Arbeitsschutz Gießen I), 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.