Accufuser M8C
by Woo Young Medical Co., Ltd. 16 variants
Ref MC124S
Active
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/MDD | NumberB-MC124S7D D-MC124S7D | Date4 Nov 2022 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- Accufuser M8C
- Model / Reference
- MC124S
- Primary DI / UDI-DI
- D-MC124S7D
- Basic UDI-DI
- B-MC124S7D
- EMDN Code
- A05010201 Elastomeric systems - variable flow w/o additional bolus
- Device Class
- Class IIb
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- KR-MF-000022134
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Woo Young Medical Co., Ltd.
Properties
Other properties (8)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Incorporates Medicinal Product: No