Identity
- Trade Name
- OPFix Soft EUDAMED
- Device Name
- OPFix EUDAMED
- Model / Reference
- HSOOPFIX800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09120047883143 EUDAMED
- Basic UDI-DI
- 912004788HSOOPFIX87 EUDAMED
- EMDN Code
- V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
OPFix Soft by MSP Medizintechnik GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union No Longer Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 912004788HSOOPFIX87 | Class I | No Longer Active |
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Manufacturer
- Manufacturer
- MSP Medizintechnik GmbH
- EUDAMED SRN
- AT-MF-000018341
Sources (1)
- EUDAMED 14c4580e-7c9a-4072-bdf2-ce60309e20ba 61 fields · synced Jul 15, 2026