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StaySure Fecal Incontinence Insert, Evaluation Kit
EUDAMEDClass IIa (EU MDR)
Ref 110115
Identity
- Trade Name
- StaySure Fecal Incontinence Insert, Evaluation Kit EUDAMED
- Device Name
- Fecal Incontinence Insert EUDAMED
- Model / Reference
- 110115 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00865453000355 EUDAMED
- Basic UDI-DI
- 08654530003101LG EUDAMED
- EMDN Code
- G99 GASTROINTESTINAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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
StaySure Fecal Incontinence Insert, Evaluation Kit by Minnesota Medical Technologies — Class IIa — 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 | 08654530003101LG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Minnesota Medical Technologies
- EUDAMED SRN
- US-MF-000008223
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (1)
- EUDAMED 384b09f6-d9b1-40da-9935-dced99096a75 61 fields · synced Oct 5, 2026