Identity
- Trade Name
- Accuryn SmartFoley Foley Adapter EUDAMED
- Device Name
- Accuryn SmartFoley Foley Adapter - 10 Pack EUDAMED
- Model / Reference
- FGS-06-UOT.SMC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10850019755197 EUDAMED
- Basic UDI-DI
- B-10850019755197 EUDAMED
- EMDN Code
- U99 DEVICES FOR UROGENITAL SYSTEM - OTHER EUDAMED
Classification
- Device Class
- Class I 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 Foley Adapter by Potrero Medical, Inc. — Class I — 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-10850019755197 | Class I | 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 7657340b-cb05-4deb-8864-4d927328371f 61 fields · synced Jun 18, 2026