Identity
- Trade Name
- NaviCam Xpress Controller EUDAMED
- Device Name
- Capsule Endoscope Controllers EUDAMED
- Model / Reference
- NaviEC-2000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921010800579 EUDAMED
- Basic UDI-DI
- 69210108N2000010200MU EUDAMED
- EMDN Code
- Z12021280 ENDOSCOPIC CAPSULE SIGNAL RECEIVERS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
NaviCam Xpress Controller by Ankon Technologies Co., Ltd. — Class I — 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 | 69210108N2000010200MU | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ANKON Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000010726
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED f907ce15-2679-4e06-ad7e-ec4f9fd77f00 61 fields · synced Jul 19, 2026