EcoCoat
by DACH Schutzbekleidung GmbH & Co. KG 6 variants
Ref 410/W/LModel Medical Gown
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
EcoCoat is a medical device used for the protection of sensitive areas, providing a sterile and controlled environment for various medical procedures. Our device has undergone rigorous testing to ensure its safety and efficacy in preventing cross-contamination.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4049825GOWNSZT 04049825003908 | Date27 Feb 2024 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- Medical Gown, 410/W/L
- Primary DI / UDI-DI
- 04049825003908
- Basic UDI-DI
- 4049825GOWNSZT
- EMDN Code
- T0205 Non-surgical gowns (excluding personal protective equipment - PPE)
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000014734
Other devices from DACH Schutzbekleidung GmbH & Co. KG
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No