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Uromedica ACT/ProACT Tissue Expanding Device II
EUDAMEDClass I (EU MDR)
Ref 750034
Identity
- Trade Name
- Uromedica ACT/ProACT Tissue Expanding Device II EUDAMED
- Device Name
- Tissue Expanding Device II- INTL EUDAMED
- Model / Reference
- 750034 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00180668000045 EUDAMED
- Basic UDI-DI
- B-00180668000045 EUDAMED
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Uromedica ACT/ProACT Tissue Expanding Device II by Uromedica, Incorporated — 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-00180668000045 | Class I | 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 b5898200-f2d7-4ce8-af26-84e5f306d4fa 61 fields · synced Jul 12, 2026