Identity
- Trade Name
- ORTHOPILOT EUDAMEDAESCULAP FDA UDI
- Generic Name
- Robotic surgical navigation system FDA UDI
- Device Name
- ORTHOPILOT transmitter EUDAMEDORTHOPILOT PASSIVE TRANSMITTER (YELLOW) FDA UDI
- Model / Reference
- FS633 EUDAMEDFDA UDI
- Description
- ORTHOPILOT PASSIVE TRANSMITTER (YELLOW) FDA UDI
Identifiers
- Catalog Number
- FS633 FDA UDI
- Primary DI / UDI-DI
- 04038653361472 EUDAMEDFDA UDI
- Basic UDI-DI
- 403923900000142122 EUDAMED
- FDA Product Code
- HAW FDA UDI
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Robotic surgical navigation system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 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
Category: Neurological stereotactic surgery system
Orthopilot by Aesculap AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 403923900000142122 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (2)
- EUDAMED 95d05437-6305-45a6-b6ef-9d9f05e4ebf0 61 fields · synced Jul 10, 2026
- FDA UDI 750da2d0-504e-47ad-8529-f447c4570d28 35 fields · synced May 30, 2026