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Varioguide Joint Array Holder
EUDAMEDFDA UDIClass I (EU MDR)
Ref 55955-30
by Brainlab SE
Identity
- Trade Name
- Varioguide Joint Array Holder EUDAMEDFDA UDI
- Generic Name
- Surgical instrument assist arm system, manually-adjusted FDA UDI
- Device Name
- VarioGuide EUDAMED
- Model / Reference
- 55955-30 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481144135 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481VarioGuideNW EUDAMED
- Direct Marketing DI
- 04056481144135 EUDAMED
- FDA Product Code
- HAW FDA UDI
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Surgical instrument assist arm system, manually-adjusted 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
Moist Heat or Steam Sterilization FDA UDI
Varioguide Joint Array Holder 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 | 4056481VarioGuideNW | 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 d5cc7492-caf2-464d-a770-9117442c7d67 61 fields · synced Jul 30, 2026
- FDA UDI b5dca724-934e-49d3-8e68-8dd55e30ed4f 33 fields · synced May 30, 2026