Identity
- Trade Name
- DUAL PEX EUDAMED
- Device Name
- Apex Locator EUDAMED
- Model / Reference
- DUAL PEX EUDAMED6080002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975132956928 EUDAMED
- Basic UDI-DI
- B-06975132956928 EUDAMED
- EMDN Code
- Z12119009 APEX LOCATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Dual Pex by Changzhou Sifary Medical Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06975132956928 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Changzhou Sifary Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010405
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED 7255b658-7d8d-4f35-8d30-ec5df9bf6de3 61 fields · synced Jul 10, 2026