Identity
- Trade Name
- Apex ID EUDAMEDFDA UDI
- Generic Name
- Endodontic apex locator FDA UDI
- Device Name
- Electronic Apex Locator EUDAMEDApex ID is an Electronic Apex Locator designed for use in measuring the working length of root canals. FDA UDI
- Model / Reference
- Apex ID EUDAMED972-0094 EUDAMEDApex ID File Holder A FDA UDI
- Description
- Apex ID is an Electronic Apex Locator designed for use in measuring the working length of root canals. FDA UDI
Identifiers
- Catalog Number
- 972-0094 FDA UDI
- Primary DI / UDI-DI
- 08809455602119 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809455602119 EUDAMED
- 510(k) Number
- K112153 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Apex ID by Meta Systems Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809455602119 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Meta Systems Co., Ltd.
- EUDAMED SRN
- KR-MF-000022945
- Authorised Representative
- Meta Biomed Europe GmbH DE-AR-000004953
Sources (2)
- EUDAMED 8d9eb909-a42a-4d11-af75-8e489fbc2404 61 fields · synced Jun 19, 2026
- FDA UDI e49e7e4e-caa0-4521-b18e-80fd6d153e10 35 fields · synced May 30, 2026