Adapter Long For Patient Reference Clamp
EUDAMEDFDA UDIClass IIa (EU MDR)
by Brainlab SE
Identity
- Trade Name
- ADAPTER LONG FOR PATIENT REFERENCE CLAMP EUDAMEDSpine Reference Adapter, Long EUDAMEDFDA UDI
- Generic Name
- Robotic surgical navigation system FDA UDI
- Device Name
- ADAPTER SHORT FOR PATIENT REFERENCE CLAMP EUDAMEDSpine & Trauma 3D Instruments EUDAMED
- Model / Reference
- 55761-02A EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481142742 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481PatRefAdapterJS EUDAMEDB-04056481142742 EUDAMED
- Direct Marketing DI
- 04056481142742 EUDAMED
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Robotic surgical navigation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass IIb 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
Yes
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
No
Category: Neurological stereotactic surgery system
Adapter Long For Patient Reference Clamp by Brainlab SE — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 4056481PatRefAdapterJS | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4056481PatRefAdapterJS | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (3)
- EUDAMED 5e72951e-4093-4b86-8303-28dcc7bc0c7e 61 fields · synced Jun 19, 2026
- EUDAMED fecb0020-5249-460b-a0aa-e39b1e417460 61 fields · synced May 18, 2026
- FDA UDI d9949dd1-63c4-4741-a6fd-9425a9601b3c 33 fields · synced May 30, 2026