Identity
- Trade Name
- Challenger® Ti-P EUDAMEDAESCULAP FDA UDI
- Generic Name
- Open-surgery ligation clip applier FDA UDI
- Device Name
- CHALLENGER TI-P handle EUDAMEDFDA UDI
- Model / Reference
- PL520R EUDAMEDFDA UDI
- Description
- CHALLENGER TI-P HANDLE FDA UDI
Identifiers
- Catalog Number
- PL520R FDA UDI
- Primary DI / UDI-DI
- 04046963313173 EUDAMEDFDA UDI
- Basic UDI-DI
- 40392390000005762R EUDAMED
- Direct Marketing DI
- 04046963313173 EUDAMED
- FDA Product Code
- FZP FDA UDI
- EMDN Code
- H03020103 REUSABLE MULTIPLE CLIP APPLIERS FOR VIDEOSURGERY EUDAMED
- GMDN Term
- Open-surgery ligation clip applier FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Challenger® Ti-P by Aesculap AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 40392390000005762R | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (2)
- EUDAMED 54576869-35d4-43a5-b837-704a8c9242f9 61 fields · synced Jul 11, 2026
- FDA UDI f42d4fe5-b4e6-47b9-9c8a-a764016ac3c5 35 fields · synced May 30, 2026