Alignment Reduction Tube Cranial 2.5/4.0
EUDAMEDFDA UDIClass I (EU MDR)
by Brainlab SE
Identity
- Trade Name
- Alignment Reduction Tube Cranial 2.5/4.0 EUDAMEDFDA UDI
- Generic Name
- Electromagnetic/optical surgical navigation device tracking system FDA UDI
- Device Name
- Alignment Reduction Tube Cranial 2.5/4.0 EUDAMED
- Model / Reference
- 56415 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481144432 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481AlignReducTubeY2 EUDAMED
- Direct Marketing DI
- 04056481144432 EUDAMED
- 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 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
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
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
For the Alignment Reduction Tube Cranial 2.5/4.0, medical professionals can use it to monitor and manage conditions such as brain development in infants or children. This device is designed for precise measurements and minimal disturbance of sensitive tissues. Its advanced features include a sterile environment and adjustable force settings, ensuring optimal results.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4056481AlignReducTubeY2 | 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 2ad4c7f2-6d83-41a5-97c3-5e6c5686318c 61 fields · synced Jul 15, 2026
- FDA UDI a174dbe2-a369-45e8-ac2c-dc55d70d773b 33 fields · synced May 30, 2026