activeDrive
by Active Medical Xcellence GmbH
Ref 1000002Model activeCut
Active
CE MDR
Valid until
15 Dec 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number111178U2 | Date7 May 2026 | StatusActive |
Certificates
- 111178U2 Active
Quality management system EU MDR
- Certifier
- SLG PRÜF UND ZERTIFIZIERUNGS GMBH 0494
- Issued
- 7 May 2026
- Expires
- 15 Dec 2030
- Reason
- Change approved
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Morcellator activeCut
- Model / Reference
- activeCut, 1000002
- Primary DI / UDI-DI
- 04069019000018
- Basic UDI-DI
- 4069019activeCut001VB
- Direct Marketing DI
- 04069019000018
- EMDN Code
- U0999 Urogenital endoscopic devices - other
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000049306
Other devices from Active Medical Xcellence GmbH
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