Identity
- Trade Name
- Accuryn SmartFoley IAP UO Temp EUDAMED
- Device Name
- Accuryn SmartFoley IAP UO Temp 16Fr - 10 Pack EUDAMED
- Model / Reference
- FGS-06-IAP.16FT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10850019755180 EUDAMED
- Basic UDI-DI
- B-10850019755180 EUDAMED
- EMDN Code
- U050402 INTRA-ABDOMINAL PRESSURE MEASUREMENT CATHETERS, WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
Accuryn SmartFoley IAP UO Temp by Potrero Medical, Inc. — Class IIa — 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-10850019755180 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Potrero Medical, Inc.
- EUDAMED SRN
- US-MF-000033318
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 5c4a23ee-8840-4ecb-898b-5d7884a7fd41 61 fields · synced Oct 6, 2026