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Pat. Ref. Attachment Arm for Skull Clamp
EUDAMEDFDA UDIClass I (EU MDR)
Ref 52001F
by Brainlab SE
Identity
- Trade Name
- Pat. Ref. Attachment Arm for Skull Clamp EUDAMEDPatient Reference Attachment Arm for Skull Clamp FDA UDI
- Generic Name
- Electromagnetic/optical surgical navigation device tracking system FDA UDI
- Device Name
- Pat. Ref. Array for Skull Clamp EUDAMED
- Model / Reference
- 52001F EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 52001F FDA UDI
- Primary DI / UDI-DI
- 04056481002503 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481PatRefSkullClampPR EUDAMED
- Direct Marketing DI
- 04056481002503 EUDAMED
- FDA Product Code
- HAW FDA UDIOLO 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 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Pat. Ref. Attachment Arm for Skull Clamp by Brainlab SE — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4056481PatRefSkullClampPR | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (2)
- EUDAMED 1801d149-0214-41b0-a0fc-920d69cbfc3e 61 fields · synced Jun 18, 2026
- FDA UDI d206ba51-56b0-4764-b25e-2e0cbc20ca3e 35 fields · synced May 30, 2026