Positive Airway Pressure Units
by Suzhou Yuyue Medical Technology Co., Ltd. 53 variants
Ref C202003, C301001, C253010, C253004, C401001, C202001, C251001, C302005, C103001, C403001, C404002, C252001, C254004, C253007, C102001, C252003, C601001, C255002, C402004, C201003, C255006, C201002, C255001, C254005, C254006, C255005, C403002, C302002, C252008, C401002, C402003, C252007, C255003, C254001, C252006, C404001, C153001Model YH-450, YH-480, YH-350, YH-550, YH-820, YH-825, YH-830, YH-820Auto, YH-825Auto, YH-680A, YH-680B, YH-690A, YH-690B, YH-360, YH-560, YH-580, Pocket X, Pocket Y, Pocket E, Pocket S, YH-720, YH-725, YH-730
Active
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69221665YHC002L6 | Date22 May 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- YH-450, YH-480, C202003, YH-350, YH-550, C301001, YH-820, YH-825, YH-830, YH-820Auto, YH-825Auto, C253010, C253004, YH-680A, YH-680B, YH-690A, YH-690B, C401001, C202001, C251001, C302005, YH-360, YH-560, YH-580, C103001, C403001, C404002, C252001, C254004, C253007, C102001, C252003, Pocket X, Pocket Y, Pocket E, Pocket S, C601001, C255002, C402004, C201003, C255006, C201002, C255001, C254005, C254006, C255005, C403002, C302002, C252008, C401002, C402003, C252007, C255003, C254001, C252006, C404001, YH-720, YH-725, YH-730, C153001
- Primary DI / UDI-DI
- 06922166511852, 06922166510398, 06922166513795, 06922166510138, 06922166512637, 06922166510237, 06922166512842, 06922166513085, 06922166500047, 06922166512330, 06922166512361, 06922166512866, 06922166512934, 06922166513009, 06922166500054, 06922166512873, 06922166513542, 06922166514303, 06922166512651, 06922166511869, 06922166512965, 06922166510954, 06922166511814, 06922166514297, 06922166512941, 06922166514310, 06922166512903, 06922166510961, 06922166512996, 06922166511821, 06922166512354, 06922166512989, 06922166512316, 06922166511807, 06922166512309, 06922166512378, 06922166510060
- Basic UDI-DI
- 69221665YHC002L6, 69221665YHC003L8, 69221665YHB002KX, 69221665YHC004LA, 69221665YHC001L4, 69221665YHC006LE, 69221665YHB001KV
- Direct Marketing DI
- 06922166511852069221665103980692216651379506922166510138069221665126370692216651023706922166512842069221665130850692216650004706922166512330069221665123610692216651286606922166512934069221665130090692216650005406922166512873069221665135420692216651430306922166512651069221665118690692216651296506922166510954069221665118140692216651429706922166512941069221665143100692216651290306922166510961069221665129960692216651182106922166512354069221665129890692216651231606922166511807069221665123090692216651237806922166510060
- EMDN Code
- Z12030102 Continuous positive pressure equipment
- Device Class
- Class IIa
- EU market of registration
- ItalyGreeceSpainPolandTürkiyeFrance
Manufacturer details
- EUDAMED SRN
- CN-MF-000015854
- Authorised representative
- Metrax GmbH DE-AR-000005481
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Properties
Other properties (12)
- 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
- Incorporates Medicinal Product: No