Blood Glucose Test Strips
Ref EN200R1、EN200R2、EN200R3、EN200R4
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-69750225319171CENMX2 D-69750225319171CENMX2 | Date13 Nov 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- Withdrawn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/IVDD Active
Specification
- Device Name
- Blood Glucose Test Strips
- Model / Reference
- EN200R1、EN200R2、EN200R3、EN200R4
- Primary DI / UDI-DI
- D-69750225319171CENMX2
- Basic UDI-DI
- B-69750225319171CENMX2
- EMDN Code
- W0101060101 Glucose test strips
- Device Class
- Class IVD General
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000036801
- Authorised representative
- MedPath GmbH DE-AR-000000087
Other devices from Eaglenos Sciences, Inc.
Properties
Other properties (6)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Companion Diagnostics: No
- Surgical Instrument: No