PROHS Horizontal Steam Sterilizer
by PROHS Equipamento Hospitalar e Serviços Associados S.A. 27 variants
Ref FJ 640L 1PD (70*70*130)
Active
CE MDR CE MDD
Valid until
23 Mar 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberES23/00000293 | Date5 Feb 2024 | StatusActive |
| European Union | CE/MDD | Number5604425SSPFF 05604425001007 | Date11 Apr 2023 | StatusActive |
Certificates
- ES23/00000293 Active
Quality management system EU MDR
- Certifier
- SGS Belgium NV 1639
- Issued
- 5 Feb 2024
- Expires
- 23 Mar 2028
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD, CE/MDR Active
Specification
- Device Name
- PROHS Horizontal Steam Sterilizer
- Model / Reference
- FJ 640L 1PD (70*70*130)
- Primary DI / UDI-DI
- 05604425001007
- Basic UDI-DI
- 5604425SSPFF, B-05604425001007
- Direct Marketing DI
- 05604425001007
- EMDN Code
- Z12011304 Autoclaves with a chamber larger than or equal to 1 standard sterilisation unit
- Device Class
- Class IIaClass IIb
- EU market of registration
- Portugal
Manufacturer details
- EUDAMED SRN
- PT-MF-000002798
Other devices from PROHS Equipamento Hospitalar e Serviços Associados S.A.
See all devices from PROHS Equipamento Hospitalar e Serviços Associados S.A. →
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