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Bone Fixator "1-Pin", X-Press Size-M
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 52422B
by Brainlab SE
Identity
- Trade Name
- Bone Fixator "1-Pin", X-Press Size-M EUDAMEDBone Fixator 1-Pin, X-Press Size-M FDA UDI
- Generic Name
- Robotic surgical navigation system FDA UDI
- Device Name
- Spine & Trauma 3D Instruments EUDAMED
- Model / Reference
- 52422B EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 52422B FDA UDI
- Primary DI / UDI-DI
- 04056481002350 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04056481002350 EUDAMED
- FDA Product Code
- HAW FDA UDIOLO FDA UDI
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Robotic surgical navigation system FDA UDI
Classification
- Device Class
- Class 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
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Bone Fixator "1-Pin", X-Press Size-M by Brainlab SE — Class IIb — 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-04056481002350 | 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 (2)
- EUDAMED 71e70d29-d058-4dbd-aaad-636f8875e05f 61 fields · synced Jun 18, 2026
- FDA UDI 7a20eb43-b5bf-4e63-a747-468b8d73336b 34 fields · synced May 29, 2026