← Back to catalogue
Cirq Robotic Biopsy Guide Tube Cranial
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 56403
by Brainlab SE
Identity
- Trade Name
- CIRQ ROBOTIC BIOPSY GUIDE TUBE CRANIAL EUDAMEDFDA UDI
- Generic Name
- Surgical instrument assist arm system, power-adjusted FDA UDI
- Device Name
- CIRQ ROBOTIC BIOPSY GUIDE TUBE CRANIAL EUDAMED
- Model / Reference
- 56403 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481141585 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04056481141585 EUDAMED
- 510(k) Number
- K210989 FDA UDI
- FDA Product Code
- HAW FDA UDI
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Surgical instrument assist arm system, power-adjusted FDA UDI
Classification
- Device Class
- Class IIa 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Moist Heat or Steam Sterilization FDA UDI
Cirq Robotic Biopsy Guide Tube Cranial by Brainlab SE — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04056481141585 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (2)
- EUDAMED 62c0aa5f-4272-42b9-ab92-cc105d959695 61 fields · synced Jun 19, 2026
- FDA UDI 6b8ca1c7-7303-427f-a99c-8df2b1290781 33 fields · synced May 30, 2026