activL®
Ref FW911R
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Overview
The activL implantation instrument IIa is a Class IIa medical device designed for minimally invasive procedures, offering precise control and accuracy. This device has undergone rigorous testing to ensure its safety and efficacy in various medical contexts.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number40392390000027062U 04046963190811 | Date10 Dec 2025 | StatusActive |
| United States | GUDID listing GUDID | Number04046963190811 | Date18 Oct 2015 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Device Name
- ACTIV L implantation instrument IIa
- Model / Ref / Catalog
- FW911R
- Primary DI / UDI-DI
- 04046963190811
- Basic UDI-DI
- 40392390000027062U
- Direct Marketing DI
- 04046963190811
- FDA Product Code
- QLQ, MJO
- EMDN Code
- L091199 Orthopaedic prosthetics instruments, reusable - other
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 888.4515
- EU market of registration
- Germany
- GUDID distribution status
- Not in Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- DE-MF-000005504
Other devices from Aesculap AG
Properties
Other properties (22)
- Sterile: No
- Single Use: 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No