Identity
- Trade Name
- SOPHY® MINI ADJUSTABLE VALVE/ 8 PRESS EUDAMEDSophysa FDA UDI
- Generic Name
- Cerebrospinal fluid shunt valve FDA UDI
- Device Name
- SOPHY® MINI ADJUSTABLE VALVE/ 8 PRESSURE EUDAMEDSOPHY MINI PROG.VALVE/8PRESS. FDA UDI
- Model / Reference
- SM8 EUDAMEDFDA UDI
- Description
- SOPHY MINI PROG.VALVE/8PRESS. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760124131093 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760124131093 EUDAMED
- 510(k) Number
- K013488 FDA UDI
- FDA Product Code
- JXG FDA UDI
- EMDN Code
- N01038002 INTRACRANIAL DRAINAGE DEVICE VALVES EUDAMED
- GMDN Term
- Cerebrospinal fluid shunt valve FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5550 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
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 Conditional FDA UDI
Category: Cerebrospinal fluid shunt valve
Sophysa by Sophysa SA — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cerebrospinal fluid shunt valve.
- Mini Integra® — Integra Lifesciences Corp. · Class II
- BioGlide® — Medtronic PS Medical · Class II
- UltraVS™ — Integra Lifesciences Corp. · Class II
- Integra® — Integra Lifesciences Corp. · Class II
- Delta® — Medtronic PS Medical · Class II
- Strata® — Medtronic PS Medical · Class II
- GAV 2.0 — AESCULAP, INC. · Class II
- miniNAV® — Christoph Miethke GmbH & Co. KG · Class II
Cleared under the same submission
K013488 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sophysa SA
Sources (2)
- FDA UDI 4862c09a-0123-4e8c-9203-558986a5638e 34 fields · synced Jun 19, 2026
- EUDAMED b482f9a1-7502-4dfc-a539-d6b61bc88c79 61 fields · synced Jun 19, 2026