Air-Lock
by Coyote O&P, Inc. 71 variants
Ref CD103SAR
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number081157602AirLock7B 00811576022521 | Date22 Aug 2023 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Air-Lock
- Model / Reference
- CD103SAR
- Primary DI / UDI-DI
- 00811576022521
- Basic UDI-DI
- 081157602AirLock7B
- EMDN Code
- Y062409, Y062415
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000018685
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Coyote O&P Inc.
Properties
Other properties (13)
- 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
- Measuring Function: No
- Incorporates Medicinal Product: No