Identity
- Trade Name
- CONTROLLER XPRESS EUDAMED
- Device Name
- NaviCam Xpress controller EUDAMED
- Model / Reference
- NaviEC-2000 EUDAMED22111L00002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971497660159 EUDAMED
- Basic UDI-DI
- 697149766NaviECJB EUDAMED
- Direct Marketing DI
- 06971497660159 EUDAMED
- EMDN Code
- Z12021202 ENDOSCOPIC CAPSULE SIGNAL RECEIVERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Hungary 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Controller Xpress by Ankon Medical Technologies (Shanghai) 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 | 697149766NaviECJB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ankon Medical Technologies (Shanghai) Co., Ltd.
- EUDAMED SRN
- CN-MF-000010409
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED 8307c07a-a6c0-4901-8f92-23a6869a7da3 61 fields · synced Jun 18, 2026