Identity
- Trade Name
- WELDON INSTRUMENTS EUDAMED
- Device Name
- WS-395-021R: Non-Sterile, Reusable, Uterine Dilator Single End 10.0mm F EUDAMED
- Model / Reference
- WS-395-021R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056863353024 EUDAMED
- Basic UDI-DI
- B-05056863353024 EUDAMED
- EMDN Code
- L0509020102 CERVICAL DILATORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Weldon Instruments by Weldon Instruments — 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-05056863353024 | Class I | Active |
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Manufacturer
- Manufacturer
- Weldon Instruments
- EUDAMED SRN
- PK-MF-000010180
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 15a69f92-b3c2-46ec-b63f-8dd73f894bb2 61 fields · synced May 21, 2026