Laryngeal Mask Airway
by Hangzhou Fushan Medical Appliances Co., Ltd. 61 variants
Ref ALMA 5.0
Active
CE MDR
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 | Number69536763LMA002QS 06953676332408 | Date25 Sep 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- Withdrawn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
- ALMA 5.0
- Primary DI / UDI-DI
- 06953676332408
- Basic UDI-DI
- 69536763LMA002QS
- EMDN Code
- R01020101 Laryngeal masks, single-lumen
- Device Class
- Class IIa
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000022768
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Hangzhou Fushan Medical Appliances Co., Ltd.
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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