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Softouch Pointer (rev 3)
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 18390-10A
by Brainlab SE
Identity
- Trade Name
- SOFTOUCH POINTER (REV 3) EUDAMEDSoftouch Pointer (Rev3) FDA UDI
- Generic Name
- Robotic surgical navigation system FDA UDI
- Device Name
- Cranial/ENT EUDAMED
- Model / Reference
- 18390-10A EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 18390-10A FDA UDI
- Primary DI / UDI-DI
- 04056481004781 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04056481004781 EUDAMED
- FDA Product Code
- HAW 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
Yes
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
Yes
FDA UDI
MR Conditional FDA UDI
Softouch Pointer (rev 3) 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-04056481004781 | 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 d95a72d7-2a74-4b3a-8793-8b17d852c449 61 fields · synced Jul 25, 2026
- FDA UDI ffa7b4de-5ef8-4998-874c-a0bc63d3446a 36 fields · synced May 30, 2026