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Cath. Ventriculaire Coude Reserv. 10 Cm
EUDAMEDFDA UDIClass III (EU MDR)
Ref PRO10
by Sophysa
Identity
- Trade Name
- CATH. VENTRICULAIRE COUDE RESERV. 10 CM EUDAMEDSophysa FDA UDI
- Generic Name
- Intracerebral infusion/drainage catheter, long-term FDA UDI
- Device Name
- Right angle ventricular catheter reservoir 10 cm EUDAMEDRIGHT ANGLE VENTRIC.CATH.RESERV.10CM FDA UDI
- Model / Reference
- PRO10 EUDAMEDFDA UDI
- Description
- RIGHT ANGLE VENTRIC.CATH.RESERV.10CM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760124130584 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760124130584 EUDAMED
- 510(k) Number
- K013488 FDA UDI
- FDA Product Code
- JXG FDA UDI
- EMDN Code
- N01038099 INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER EUDAMED
- GMDN Term
- Intracerebral infusion/drainage catheter, long-term FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5550 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- Not 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
Yes
FDA UDI
MR Safe FDA UDI
Cath. Ventriculaire Coude Reserv. 10 Cm 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-03760124130584 | 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 825d81c9-5329-4bab-a3a8-336be4ea89c1 61 fields · synced Jul 9, 2026
- FDA UDI e6242f3b-3984-4ab4-bb99-7a77d1705145 35 fields · synced May 30, 2026