Single-use Laryngoscope Blade
by Shenzhen HugeMed Medical Technical Development Co., Ltd. 25 variants
Ref HF 4Model MAC1, MAC2, MAC3, MAC3-1, MAC4, MAC5, MILLER00, MILLER0, CMAC3, CMAC4, CMAC5, HF 0, HF 1, HF M1, HF 2, HF 3, HF 4
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 | Number6970462548803A3 06970462540823 | Date11 Sep 2024 | 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- Withdrawn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
- Device Name
- Single-use Laryngoscope Blade
- Model / Reference
- MAC1, MAC2, MAC3, MAC3-1, MAC4, MAC5, MILLER00, MILLER0, CMAC3, CMAC4, CMAC5, HF 0, HF 1, HF M1, HF 2, HF 3, HF 4
- Primary DI / UDI-DI
- 06970462540823
- Basic UDI-DI
- 6970462548803A3
- EMDN Code
- R9002 Laryngoscope blades, single-use
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000010895
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Shenzhen HugeMed Medical Technical Development 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