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Kit Polaris® Spvb Preconnecte / Bo19-10
EUDAMEDFDA UDIClass III (EU MDR)
Ref SPVB-2010
by Sophysa
Identity
- Trade Name
- KIT POLARIS® SPVB PRECONNECTE / BO19-10 EUDAMEDSophysa FDA UDI
- Generic Name
- Ventriculo-peritoneal/atrial shunt FDA UDI
- Device Name
- POLARIS® SPVB KIT PREATTACHED / BO19-10 EUDAMEDPOLARIS SPVB KIT PREATTACHED/BO19-10 FDA UDI
- Model / Reference
- SPVB-2010 EUDAMEDFDA UDI
- Description
- POLARIS SPVB KIT PREATTACHED/BO19-10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760124131338 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760124131338 EUDAMED
- FDA Product Code
- JXG FDA UDI
- EMDN Code
- N01038099 INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER EUDAMED
- GMDN Term
- Ventriculo-peritoneal/atrial shunt FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5550 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Kit Polaris® Spvb Preconnecte / Bo19-10 by Sophysa — Class III — 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-03760124131338 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Sophysa
- EUDAMED SRN
- FR-MF-000002870
Sources (2)
- EUDAMED 19113b12-7199-448a-b5dc-f619e2ead6ca 61 fields · synced Jun 18, 2026
- FDA UDI 9f8a0b05-33eb-4546-825a-3b1a6b3cee66 33 fields · synced May 30, 2026