Challenger® Ti-P
by Aesculap AG Germany EUDAMEDGUDID
Ref PL603R
Product code FZPEMDN H03020103
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number40392390000005752P | Date18 Nov 2025 | StatusActive |
| United States | GUDID listing GUDID | Number04046963356002 | Date16 May 2017 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Challenger® Ti-P EUDAMEDAesculap GUDID
- Generic Name
- Open-surgery ligation clip applier
- Model / Ref / Catalog
- PL603R
- Primary DI / UDI-DI
- 04046963356002
- Basic UDI-DI
- 40392390000005752P
- FDA Product Code
- FZP
- EMDN Code
- H03020103 Reusable multiple clip appliers for videosurgery
- GMDN Term
- Open-surgery ligation clip applier
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 878.4300
- Market of Registration
- Germany
- Commercial Distribution
- 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 & raw data
Show properties, registry sources and raw records
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
Sources (2)
- EUDAMED c2b28180-b367-459e-b805-ab5cdf3dd5d3
- FDA UDI 171ec45d-e6b2-41fc-a6d1-a7eeb4ecf1bc