Identity
- Trade Name
- Genareal EUDAMED
- Device Name
- Patient Monitor EUDAMED
- Model / Reference
- G3D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938368100190 EUDAMED
- Basic UDI-DI
- B-06938368100190 EUDAMED
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
Genareal by General Meditech, Inc. — 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-06938368100190 | Class IIb | Active |
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Manufacturer
- Manufacturer
- General Meditech, Inc.
- EUDAMED SRN
- CN-MF-000002906
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 4954840a-d4e5-4173-9129-b5358ac27fe9 61 fields · synced Jul 29, 2026