Scooter
by INTCO MEDICAL (HK) CO., ltd 4 variants
Ref SAGITTA-D, LIBRA-D, PLAZA Elite Max Super, Plzaz Elite, Libra-DModel Virgo-D、Virgo-F、Virgo-DL、Sagitta-D、Libra-D、Libra-DX、Libra-DLX、 Gemini、E-Cary
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 | Number489712866-0-Escooter7Z | Date1 Dec 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- Withdrawn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
- Model / Reference
- Virgo-D、Virgo-F、Virgo-DL、Sagitta-D、Libra-D、Libra-DX、Libra-DLX、 Gemini、E-Cary, SAGITTA-D, LIBRA-D, PLAZA Elite Max Super, Plzaz Elite
- Primary DI / UDI-DI
- 04897128665510, 04897128665503, 04895272901669, 04895272901645, 04895272903069
- Basic UDI-DI
- 489712866-0-Escooter7Z
- Direct Marketing DI
- 0489712866551004897128665503048952729016690489527290164504895272903069
- EMDN Code
- Y122124 Electric scooters
- Device Class
- Class I
- EU market of registration
- AustriaNetherlandsGermany
Manufacturer details
- EUDAMED SRN
- CN-MF-000011338
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from INTCO MEDICAL (HK) CO., ltd
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