Identity
- Trade Name
- E-PEX EUDAMED
- Model / Reference
- E-PEX EUDAMED6180002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972597780891 EUDAMED
- Basic UDI-DI
- B-06972597780891 EUDAMED
- EMDN Code
- Z12119009 APEX LOCATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Latvia 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
E-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-06972597780891 | 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 ff47e196-84eb-4507-85d2-6335093cf860 61 fields · synced Jul 26, 2026