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Sophy® Sm1-H Valve / Burr Hole Reservoir
EUDAMEDClass III (EU MDR)
Ref SM1B-H
by Sophysa
Identity
- Trade Name
- SOPHY® SM1-H VALVE / BURR HOLE RESERVOIR EUDAMED
- Device Name
- SOPHY® SM1-H VALVE / BURR HOLE RESERVOIR EUDAMED
- Model / Reference
- SM1B-H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760124131024 EUDAMED
- Basic UDI-DI
- B-03760124131024 EUDAMED
- EMDN Code
- N01038099 INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Sophy® Sm1-H Valve / Burr Hole Reservoir by Sophysa — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03760124131024 | Class III | Active |
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Manufacturer
- Manufacturer
- Sophysa
- EUDAMED SRN
- FR-MF-000002870
Sources (1)
- EUDAMED 37e60a8b-777c-49f0-a27d-e463344b9e30 61 fields · synced Jul 10, 2026