Oropharyngeal Airway
by Well Lead Medical Co., Ltd. 14 variants
Ref A06B020620, A06B01071X, A06B020820, A06B01081X, A06B01111X, A06B011110, A06B01041X, A06B010410, A06B01091X, A06B01101X, A06B020720, A06B011010Model Guedel, Berman(Non-Sterile), Berman
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 | Number69449327FA06B01D8 | Date14 Apr 2026 | 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- Withdrawn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
- Guedel, A06B020620, Berman(Non-Sterile), A06B01071X, A06B020820, A06B01081X, A06B01111X, Berman, A06B011110, A06B01041X, A06B010410, A06B01091X, A06B01101X, A06B020720, A06B011010
- Primary DI / UDI-DI
- 06936881159275, 06944932776319, 06936881159299, 06944932776326, 06944932776364, 06944932776357, 06944932776289, 06944932703711, 06944932776333, 06944932776340, 06936881159282, 06944932703773
- Basic UDI-DI
- 69449327FA06B01D8, 69449327FA06B04DE, 69449327FA06B02DA
- EMDN Code
- R010102 Guedel airway tubes
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000006728
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Well Lead Medical Co., Ltd
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