Filter
by Hangzhou Shanyou Medical Equipment Co., Ltd.
Ref FH1-FModel Adult
Filter (FH1-F) is a Class IIa device made by Hangzhou Shanyou Medical Equipment Co., Ltd., registered in EUDAMED on 21 Sep 2026 (Basic UDI-DI 69447465FHGR), active as of 7 Nov 2026.
Active
CE MDR CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | Number69447465FHGR 06944746598589 | Date21 Sep 2026 | StatusActive |
| European Union | CE/MDR | Number69447465FHGR 06944746598589 | Date21 Sep 2026 | StatusActive |
Official records
- EUDAMED public site 69447465FHGR
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD, CE/MDR Active
Specification
- Device name
- Filters/HMEF
- Model / reference
- Adult, FH1-F
- Primary DI / UDI-DI
- 06944746598589
- Basic UDI-DI
- 69447465FHGR, B-06944746598589
- EMDN code
- R040101 Antibacterial and antiviral respiratory filters
- Device class
- Class IIa
- EU registration type
- Standard deviceLegacy device (under a directive)
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000018226
- Authorised representative
- Prolinx GmbH DE-AR-000005129
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