Identity
- Trade Name
- ENDODIGI HD EUDAMED
- Device Name
- ENDODIGI HD EUDAMED
- Model / Reference
- U1EN105/2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B366U1EN1052 EUDAMED
- Basic UDI-DI
- ++B366ENDODIGIHDKF EUDAMED
- Direct Marketing DI
- B366U1EN1052 EUDAMED
- EMDN Code
- Z119007 IMAGE ACQUISITION MODULES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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
Endodigi Hd by EUSA Global Llc. — 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 | ++B366ENDODIGIHDKF | Class I | Active |
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Manufacturer
- Manufacturer
- EUSA Global Llc.
- EUDAMED SRN
- US-MF-000003607
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED f05c72a0-98f5-4e66-9788-61cb905914de 61 fields · synced Jun 19, 2026