AcoArt Tulip
by Acotec Scientific Co., Ltd 552 variants
Ref TUL60020BGModel TUL12120FG
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-06955139287065 06955139287065 | Date18 Aug 2026 | 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- Withdrawn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
- Drug Eluting Balloon Catheters (AcoArt Tulip)
- Model / Reference
- TUL12120FG, TUL60020BG
- Primary DI / UDI-DI
- 06955139287065
- Basic UDI-DI
- B-06955139287065
- EMDN Code
- C010402020101 PTA balloon dilatation catheters
- Device Class
- Class III
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000015843
- Authorised representative
- MedDevConsult GmbH DE-AR-000005877
Other devices from Acotec Scientific Co., Ltd.
Properties
Other properties (10)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No