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Wirele-X Apex Locator
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 5-WLX-000Model Wirele-XRef 5-W11-000Model Wirele-X
Identity
- Trade Name
- Wirele-X Apex Locator EUDAMEDWirelex FDA UDI
- Generic Name
- Endodontic apex locator FDA UDI
- Device Name
- Wirele-X Apex Locator EUDAMEDFDA UDI
- Model / Reference
- Wirele-X EUDAMED5-WLX-000 EUDAMED5-W11-000 EUDAMEDW-31 FDA UDI
- Description
- Wirele-X Apex Locator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290114354004 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07290114354004 EUDAMED729011435400A2 EUDAMED
- Direct Marketing DI
- 07290114354004 EUDAMED
- 510(k) Number
- K121206 FDA UDI
- FDA Product Code
- LQY FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Endodontic apex locator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDU FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Wirele-X Apex Locator by Forum Engineering Technologies (96) Ltd. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07290114354004 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07290114354004 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Forum Engineering Technologies (96) Ltd.
- EUDAMED SRN
- IL-MF-000023254
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (3)
- EUDAMED 07bad0fa-dc94-4901-9b53-6fd5340de1b2 61 fields · synced Jul 25, 2026
- EUDAMED 91a85f4d-f1d4-4408-bedd-c4a656791244 61 fields · synced May 19, 2026
- FDA UDI 1f6425e5-22f2-4566-ad31-01edc39e5e39 34 fields · synced May 30, 2026