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Curve Navigation 17700
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 17701Ref 17702
by Brainlab SE
Identity
- Trade Name
- Curve Navigation 17700 EUDAMEDFDA UDICurve Navigation EUDAMED
- Generic Name
- Electromagnetic/optical surgical navigation device tracking system FDA UDI
- Device Name
- Curve Navigation 17700 EUDAMEDCurve Navigation EUDAMED
- Model / Reference
- 17701 EUDAMEDFDA UDI17702 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056481144500 EUDAMEDFDA UDI04056481146702 EUDAMED
- Basic UDI-DI
- 4056481PlatformsMR EUDAMED4056481CurveNavigationEB EUDAMED
- 510(k) Number
- K213989 FDA UDIK221618 FDA UDIK223288 FDA UDIK223734 FDA UDIK223864 FDA UDIK243698 FDA UDI
- FDA Product Code
- HAW FDA UDIPGW 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 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
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
Yes
FDA UDI
Curve Navigation 17700 by Brainlab SE — Class IIb — 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 | 4056481PlatformsMR | 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 2107f22c-ef03-4f4c-8145-7671b4017451 61 fields · synced Jul 19, 2026
- EUDAMED 94070097-c994-4f36-8b8c-c31b2a5f05b3 61 fields · synced May 18, 2026
- FDA UDI de39d4df-65f9-4a11-91a1-56f29208d60a 33 fields · synced May 30, 2026