Blood Glucose, Ketone and Uric Acid Meters
by Beijing Lepu Medical Technology Co., Ltd.
Ref JY15Poctor M3101Model PoctorM3101
Active
CE IVDD
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/IVDD | NumberB-06921807611326 06921807611326 | Date10 Jan 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Model / Reference
- PoctorM3101, JY15Poctor M3101
- Primary DI / UDI-DI
- 06921807611326
- Basic UDI-DI
- B-06921807611326
- EMDN Code
- W02029099 Various hematology / histology / cytology instruments - other
- Device Class
- Class IVD devices for self-testing
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000033011
- Authorised representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Other devices from Beijing Lepu Medical Technology Co., Ltd.
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Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No