Bone Fixator “2-Pin”, X-Press
EUDAMEDFDA UDIClass IIb (EU MDR)
by Brainlab SE
Identity
- Trade Name
- Bone Fixator “2-Pin”, X-Press EUDAMEDBONE FIXATOR 2-PIN X-PRESS EUDAMEDFDA UDI
- Generic Name
- Electromagnetic/optical surgical navigation device tracking system FDA UDI
- Device Name
- Spine & Trauma 3D Instruments EUDAMEDBONE FIXATOR 2-PIN X-PRESS EUDAMED
- Model / Reference
- 52429 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 52429 FDA UDI
- Primary DI / UDI-DI
- 04056481005955 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04056481005955 EUDAMED4056481XPressFixatorN2 EUDAMED
- Direct Marketing DI
- 04056481005955 EUDAMED
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electromagnetic/optical surgical navigation device tracking system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass 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
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
Yes
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
Bone Fixator “2-Pin”, X-Press by Brainlab SE — Class IIb — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04056481005955 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-04056481005955 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (3)
- EUDAMED 40ab69c7-eae1-41f4-9ca4-d774d66446c9 61 fields · synced Jul 16, 2026
- EUDAMED 725f23c8-0669-437f-828d-f12aaecd86a3 61 fields · synced May 19, 2026
- FDA UDI a959bbc9-3dd7-4eef-b8d3-a048558ba669 35 fields · synced May 30, 2026