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RomiApex A-15
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 5-A32-004 Model NovApexRef 5-A32-004Model RomiApex A-15
Identity
- Trade Name
- RomiApex A-15 EUDAMEDRomiApex A-15 Apex Locator EUDAMEDRomiApex FDA UDI
- Generic Name
- Endodontic apex locator FDA UDI
- Device Name
- RomiApex A-15 EUDAMEDRomiApex A-15 Apex Locator EUDAMEDFDA UDI
- Model / Reference
- NovApex EUDAMED5-A32-004 EUDAMEDRomiApex A-15 EUDAMEDA-15 FDA UDI
- Description
- RomiApex A-15 Apex Locator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290114353007 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07290114353007 EUDAMED7290114353009V EUDAMED
- Direct Marketing DI
- 07290114353007 EUDAMED
- 510(k) Number
- K101054 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
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
Moist Heat or Steam Sterilization FDA UDI
RomiApex A-15 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-07290114353007 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07290114353007 | 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 1b818854-86e7-4ad9-a80a-23f48a863c29 61 fields · synced Jul 9, 2026
- EUDAMED b4f414da-8d8e-4340-b234-3a4cd9173070 61 fields · synced May 18, 2026
- FDA UDI 3d624b91-7ba5-4d59-bca8-7d718b34ce16 34 fields · synced May 30, 2026