Sterile Standard Surgical Gowns
by Kenpax International Limited EUDAMED
Active
Ref 67-5148-SModel Standard Gown; Standard Plus Gown; Performance Plus Gown; Premium Performance Plus Gown; EN Standard S.Gown+1 Towels+CSR M-XXL; EN Standard Surgical Gown+2 Towels+CSR M-XXL; EN Standard Surgical Gown+2 Towels+CSR L-XXL Long; etc.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number48952371001UR | Date8 Mar 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- Standard Gown, Standard Plus Gown, Performance Plus Gown, Premium Performance Plus Gown, EN Standard S.Gown+1 Towels+CSR M-XXL, EN Standard Surgical Gown+2 Towels+CSR M-XXL, EN Standard Surgical Gown+2 Towels+CSR L-XXL Long, etc., 67-5148-S
- Primary DI / UDI-DI
- 04895237110563
- Basic UDI-DI
- 48952371001UR
- EMDN Code
- T020401 Standard surgical gowns
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- HK-MF-000021152
- Authorised representative
- MedPath GmbH DE-AR-000000087
Other devices from Kenpax International Limited
Properties
Other properties (12)
- 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