Identity
- Trade Name
- Apex Connect FDA UDI
- Generic Name
- Endodontic apex locator FDA UDI
- Device Name
- Apex Connect Probe Cord FDA UDI
- Model / Reference
- 815-1812 FDA UDI
- Description
- Apex Connect Probe Cord FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809455601983 FDA UDI
- FDA Product Code
- LQY FDA UDI
- GMDN Term
- Endodontic apex locator FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Endodontic apex locator
Apex Connect by Meta Systems Co., Ltd. — Class U — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class U | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Meta Systems Co., Ltd.
Sources (2)
- FDA UDI aecd8de3-cd47-4b68-b9e8-bf032b1d5c4a 33 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced May 29, 2026