Identity
- Trade Name
- WELDON INSTRUMENTS EUDAMED
- Device Name
- WS-160-014R: Non-Sterile, Reusable, Wolff Plaster Cast Instrument 24.0cm / 9 ½” EUDAMED
- Model / Reference
- WS-160-014R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056863321955 EUDAMED
- Basic UDI-DI
- B-05056863321955 EUDAMED
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER 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
Category: Surgical retraction system, reusable
Weldon Instruments by Weldon Instruments — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical retraction system, reusable.
- 45930R — Thompson Surgical Instruments, Inc. · Class IIa
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- Omni-Tract® — Integra Lifesciences Corp. · Class I
- Drills and Handpieces — SOUTHERN IMPLANTS (PTY) LTD · Class IIa
- Thompson — Thompson Surgical Instruments · Class I
- Nordent Manufacturing, Inc. — NORDENT MANUFACTURING INC · Class I
- Thompson — Thompson Surgical Instruments · Class I
- Thompson — Thompson Surgical Instruments · Class I
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-05056863321955 | 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 6098115e-a81d-4d2d-a56e-9472a8a079df 61 fields · synced May 22, 2026