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 EUDAMED972-0085 EUDAMEDApex ID Main Body 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
- 972-0085 FDA UDI
- Primary DI / UDI-DI
- 08809455602089 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809455602089 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
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-08809455602089 | 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 0ec8f0c0-c2f1-4c1a-a3c7-e62b2d6385a9 61 fields · synced Jul 29, 2026
- FDA UDI 8cf74977-9ea6-41ee-a3a3-abef01c45f42 35 fields · synced May 30, 2026