Rapid Intervention Capnograph
by Shenzhen Witleaf Medical Electronics Co., Ltd
Ref RICap, Capnocop
Active
CE MDR CE MDD
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 | NumberB-06970005397112 | Date31 Oct 2024 | StatusActive |
| European Union | CE/MDD | NumberB-06970005397112 | Date31 Oct 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- Withdrawn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, CE/MDD Active
Specification
- Model / Reference
- RICap, Capnocop
- Primary DI / UDI-DI
- 06970005397112, 06970005397129
- Basic UDI-DI
- B-06970005397112, 697000539RIC21C8
- Direct Marketing DI
- 0697000539711206970005397129
- EMDN Code
- Z1203020401 Carbon dioxide analysers
- Device Class
- Class IIb
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000040494
- Authorised representative
- Zug Medical Systems FR-AR-000032031
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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