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Sophy® Sm1a-H Kit Preattached / Bo19-10
EUDAMEDClass III (EU MDR)
Ref SM1A-2010H
by Sophysa
Identity
- Trade Name
- SOPHY® SM1A-H KIT PREATTACHED / BO19-10 EUDAMED
- Device Name
- SOPHY® SM1A-H KIT PREATTACHED/ BO19-10 EUDAMED
- Model / Reference
- SM1A-2010H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760124131901 EUDAMED
- Basic UDI-DI
- B-03760124131901 EUDAMED
- EMDN Code
- N01038099 INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Croatia 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® Sm1a-H Kit Preattached / Bo19-10 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-03760124131901 | Class III | Active |
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Manufacturer
- Manufacturer
- Sophysa
- EUDAMED SRN
- FR-MF-000002870
Sources (1)
- EUDAMED e151535a-80c9-49de-8579-e7ffd2745ab2 61 fields · synced Jul 18, 2026