← Back to catalogue
Apex Locator
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref Annex IX of Regulation EU 2017/745(MDR)Model AL-Pex+, AL-Pex
Identity
- Trade Name
- Apex Locator EUDAMED
- Device Name
- Apex Locator EUDAMED
- Model / Reference
- AL-Pex+, AL-Pex EUDAMEDAnnex IX of Regulation EU 2017/745(MDR) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975565690031 EUDAMED
- Basic UDI-DI
- 697556569AL5Z EUDAMED
- Direct Marketing DI
- 06975565690031 EUDAMED
- EMDN Code
- Z12119009 APEX LOCATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Apex Locator by Changzhou Haili Medical Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232717 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697556569AL5Z | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Changzhou Haili Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000034967
- Authorised Representative
- phoenix Medtech GmbH DE-AR-000007996
Sources (2)
- EUDAMED 2f34cf72-777e-437b-83c7-3089a7b1bfc5 61 fields · synced Jul 8, 2026
- FDA 510(k) K232717 1 fields · synced May 18, 2026