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Cirq Robotic Disposable Kinematic Unit
EUDAMEDFDA UDIClass I (EU MDR)
Ref 56102-01
by Brainlab SE
Identity
- Trade Name
- Cirq Robotic Disposable Kinematic Unit EUDAMEDFDA UDI
- Generic Name
- Surgical instrument assist arm system, power-adjusted FDA UDI
- Device Name
- Cirq Robotic Disposable Kinematic Unit EUDAMED
- Model / Reference
- 56102-01 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481144319 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481KinematicUnitMA EUDAMED
- FDA Product Code
- OLO FDA UDIHAW FDA UDI
- EMDN Code
- Z12011485 SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Surgical instrument assist arm system, power-adjusted 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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Cirq Robotic Disposable Kinematic Unit by Brainlab SE — Class I — 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 | 4056481KinematicUnitMA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (2)
- EUDAMED cbdb331c-3d09-4867-806b-480228e7d6ee 61 fields · synced Jul 10, 2026
- FDA UDI b28093b7-e379-44bc-9fcb-200fa3380040 33 fields · synced May 30, 2026