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OPTIFLUID Stoma Oil 25 ml
EUDAMEDClass I (EU MDR)
Ref 331525Model 659
by PRISMAN GmbH
Identity
- Trade Name
- OPTIFLUID Stoma Oil 25 ml EUDAMED
- Device Name
- Medizinisches Gleitöl (incl. Aerosol und Tücher) EUDAMED
- Model / Reference
- 659 EUDAMED331525 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04064797029961 EUDAMED
- Basic UDI-DI
- ++EPRM659EX EUDAMED
- EMDN Code
- M9002 PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
OPTIFLUID Stoma Oil 25 ml by PRISMAN GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++EPRM659EX | Class I | Active |
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Manufacturer
- Manufacturer
- PRISMAN GmbH
- EUDAMED SRN
- DE-MF-000009900
Sources (1)
- EUDAMED 37f25298-e4dd-488a-929f-5f383c9727e1 61 fields · synced Jun 19, 2026