MCM Sheath
by Changchun Medicside Medical Technology Co., Ltd 12 variants
Ref 410204024Model MA-500 and CM series urinalysis system
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697423503UMA0004JX 06974235033796 | Date26 Dec 2022 | 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- Withdrawn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/IVDR Active
Specification
- Device Name
- MCM Sheath
- Model / Reference
- MA-500 and CM series urinalysis system, 410204024
- Primary DI / UDI-DI
- 06974235033796
- Basic UDI-DI
- 697423503UMA0004JX
- Direct Marketing DI
- 06974235033796
- EMDN Code
- W01019001 Buffers (unassignable), supplem. reagents, etc (cc)
- Device Class
- Class A
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- CN-MF-000022835
- Authorised representative
- Umedwings Netherlands B.V. NL-AR-000000444
Other devices from Changchun Medicside Medical Technology Co., Ltd
See all devices from Changchun Medicside Medical Technology Co., Ltd →
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No