Z-touch Laser Registration Pointer
EUDAMEDFDA UDIClass IIb (EU MDR)
by Brainlab SE
Identity
- Trade Name
- Z-touch Laser Registration Pointer EUDAMEDFDA UDI
- Generic Name
- Electromagnetic/optical surgical navigation device tracking system FDA UDI
- Device Name
- Z-touch Laser Registration Pointer EUDAMEDThe Z-touch Laser Registration Pointer is a battery powered wireless laser pointer for quick and accurate patient registration without fiducials. FDA UDI
- Model / Reference
- 18370-10A EUDAMEDFDA UDI
- Description
- The Z-touch Laser Registration Pointer is a battery powered wireless laser pointer for quick and accurate patient registration without fiducials. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481145514 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481Z-touchP8 EUDAMED
- Direct Marketing DI
- 04056481145514 EUDAMED
- 510(k) Number
- K192703 FDA UDI
- FDA Product Code
- HAW 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 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
No
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
Yes
Category: Neurological stereotactic surgery system
Z-touch Laser Registration Pointer by Brainlab SE — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neurological stereotactic surgery system.
- PEEK INSTRUMENT ADAPTOR Ø2.15MM — MEDTECH LLC · Class II
- Mini-Bolt VUE Accessory Kit — MONTERIS MEDICAL CORP · Class I
- StealthAiR™ Spine — MEDTRONIC NAVIGATION, INC. · Class II
- StealthStation — MEDTRONIC NAVIGATION, INC. · Class II
- OsteoMed™ Manual Driver Handle — FHC, INC. · Class II
- PMT CORPORATION - STEREOTACTIC — Pmt Corp. · Class II
- Leksell Stereotactic System — Elekta Instrument AB · Class II
- Leksell Stereotactic System — Elekta Instrument AB · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4056481Z-touchP8 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (2)
- EUDAMED 0ee188a0-3be6-4ad3-a8f1-678208187f34 61 fields · synced Jul 26, 2026
- FDA UDI e79ae05e-a428-4fd0-85a1-4793506670e3 35 fields · synced May 29, 2026