Identity
- Trade Name
- SOLOASSIST II EUDAMEDFDA UDI
- Generic Name
- Surgical camera holder FDA UDI
- Device Name
- SOLOASSIST II EUDAMED
- Model / Reference
- 141364 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260463843644 EUDAMEDFDA UDI
- Basic UDI-DI
- 4260463840018T EUDAMED
- FDA Product Code
- NAY FDA UDI
- EMDN Code
- Z1202018001 ROBOTIC ARMS FOR VIDEOENDOSCOPY EUDAMED
- GMDN Term
- Surgical camera holder FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Austria 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Soloassist Ii by Aktormed GmbH — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171947 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 4260463840018T | Class I | Active |
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Manufacturer
- Manufacturer
- AKTORmed GmbH
- EUDAMED SRN
- DE-MF-000006136
Sources (3)
- EUDAMED ea20e370-296e-41b1-9277-12dbbd2b3f2b 61 fields · synced Jul 20, 2026
- FDA UDI 2907d328-f51d-46f7-a689-5d6184b04355 32 fields · synced May 30, 2026
- FDA 510(k) K171947 1 fields · synced May 18, 2026