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XCEL Detachment Controller
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref XCEL
by Balt Usa Llc
Identity
- Trade Name
- XCEL Detachment Controller EUDAMEDXCEL Detach FDA UDI
- Generic Name
- Vascular implant detacher, electronic, single-use FDA UDI
- Device Name
- XCEL Detachment Controller EUDAMEDThe XCEL Detachment Controller is used in conjunction with the Optima Coil System and separates the coils from the pusher system. FDA UDI
- Model / Reference
- XCEL EUDAMEDFDA UDI
- Description
- The XCEL Detachment Controller is used in conjunction with the Optima Coil System and separates the coils from the pusher system. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818053022579 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00818053022579 EUDAMED
- FDA Product Code
- HCG FDA UDI
- EMDN Code
- Z12109099 VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Vascular implant detacher, electronic, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5950 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
XCEL Detachment Controller by Balt Usa Llc — Class IIa — 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-00818053022579 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Balt Usa Llc
- EUDAMED SRN
- US-MF-000008651
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 3f7037ea-cfd1-45cf-821c-b801b27b2f81 61 fields · synced Jun 18, 2026
- FDA UDI b464e0d4-7a78-4d20-aefe-b7fbf78d48e0 35 fields · synced May 29, 2026