Cirq Arm System 2.0
FDA UDIEUDAMEDClass II (US FDA UDI)
by Brainlab SE
Identity
- Trade Name
- Cirq Arm System 2.0 EUDAMEDFDA UDI
- Generic Name
- Surgical instrument assist arm system, power-adjusted FDA UDI
- Device Name
- Cirq Arm System EUDAMED
- Model / Reference
- 56500 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481143961 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481CirqArmT3 EUDAMED
- Direct Marketing DI
- 04056481143961 EUDAMED
- FDA Product Code
- HAW FDA UDIOLO 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 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Surgical instrument assist arm system, power-adjusted
Cirq Arm System 2.0 by Brainlab SE — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument assist arm system, power-adjusted.
- Micro Manipulator PSMP — MITAKA KOHKI CO., LTD. · Class II
- LANDANGER — LANDANGER · Class I
- LANDANGER — LANDANGER · Class I
- LANDANGER — LANDANGER · Class I
- VITOM — Karl Storz GmbH & Co. KG · Class I
- Universal Adapter 10-15mm — MITAKA KOHKI CO., LTD. · Class II
- POINT SETTER — Karl Storz GmbH & Co. KG · Class I
- LANDANGER — LANDANGER · Class I
Cleared under the same submission
K223864 also covers:
K243698 also covers:
- Alignment Software Cranial with LITT — Brainlab AG
- Alignment Bone Anchor Cranial 2.1 mm / 4.9 mm — Brainlab SE
- Alignment Guide Tube Cranial 4.9 mm / 8.0 mm — Brainlab SE
- Alignment Reduction Tube Cranial 8.0 mm / 10.0 mm — Brainlab SE
- Curve Navigation 17700 — Brainlab SE
- Drill Bit Cranial 4.5 mm /4.9 mm — Brainlab SE
- Drill Depth Stop Cranial 4.9 mm — Brainlab SE
- Sterilization Tray Cirq® Robotic Alignment LITT — Brainlab SE
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Brainlab SE
Sources (2)
- FDA UDI 2bcdd8c6-2adf-4444-8050-832633e29d96 33 fields · synced Jun 20, 2026
- EUDAMED 27be9ac7-9ccb-486c-b494-dc10897897cb 61 fields · synced Jun 20, 2026