Identity
- Trade Name
- 8cm ACT Double- INTL EUDAMED
- Device Name
- 8cm ACT Double- INTL EUDAMED
- Model / Reference
- 800016-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00180668000281 EUDAMED
- Basic UDI-DI
- B-00180668000281 EUDAMED
- EMDN Code
- P080199 URINARY INCONTINENCE PROSTHESES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
8cm ACT Double- INTL by Uromedica, Incorporated — Class IIb — 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-00180668000281 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Uromedica, Incorporated
- EUDAMED SRN
- US-MF-000008932
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (1)
- EUDAMED 36f7e60c-0a7b-4836-bc12-47fd5b45dc15 61 fields · synced Jun 18, 2026