Identity
- Trade Name
- Apex Locator EUDAMED
- Device Name
- Apex Locator EUDAMED
- Model / Reference
- RPEX 6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975980900340 EUDAMED
- Basic UDI-DI
- 6975980900002FH EUDAMED
- EMDN Code
- Z12119009 APEX LOCATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Apex Locator by Guangzhou RebornEndo Medical Instrument Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6975980900002FH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangzhou RebornEndo Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000039642
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 874bdc65-4435-426f-a41d-f3d2e65523d3 61 fields · synced Jun 19, 2026