Reusable technical fabric gowns and coveralls for sterilization kits for healthcare use
Ref CA 004Model Reusable technical fabric gowns and coveralls for sterilization kits for healthcare use
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805620146CAQ2 08056201463597 | Date31 Jul 2025 | 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- Withdrawn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
- Device Name
- Reusable technical fabric gowns and coveralls for sterilization kits for healthcare use
- Model / Reference
- Reusable technical fabric gowns and coveralls for sterilization kits for healthcare use, CA 004
- Primary DI / UDI-DI
- 08056201463597
- Basic UDI-DI
- 805620146CAQ2
- EMDN Code
- T020401 Standard surgical gowns
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000028023
From the manufacturer
Manufacturer's product page: Informativa sui rimborsi
Other devices from T.H. Service SRL
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: 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