Identity
- Trade Name
- U-FLEX URETERAL ACCESS SHEATH EUDAMED
- Device Name
- U-FLEX URETERAL ACCESS SHEATH EUDAMED
- Model / Reference
- 00819374021609 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00819374021609 EUDAMED
- Basic UDI-DI
- 081226101UAS012SH EUDAMED
- EMDN Code
- U0399 DEVICES FOR URINARY TRACT DILATION - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
Yes
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
U-Flex Ureteral Access Sheath by Allwin Medical Devices, Inc. — Class I — 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 | 081226101UAS012SH | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Allwin Medical Devices, Inc
- EUDAMED SRN
- US-MF-000011349
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED d5059e2a-e5f4-4c74-bcfb-6c7bed1171b4 61 fields · synced Jul 28, 2026