Identity
- Device Name
- Smart 3 EUDAMED
- Model / Reference
- 35.11-4200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-35.11-4200UR EUDAMED
- Basic UDI-DI
- B-35.11-4200UR EUDAMED
- EMDN Code
- Z12080101 FOETAL MONITORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Smart 3 by medical ECONET GmbH — Class IIb — 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-35.11-4200UR | Class IIb | Active |
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Manufacturer
- Manufacturer
- medical ECONET GmbH
- EUDAMED SRN
- DE-MF-000004982
Sources (1)
- EUDAMED 37205c83-2b2a-47ec-9a28-496d587fcb6c 61 fields · synced Jul 9, 2026