Identity
- Trade Name
- ENG 4000 (Electronystagmograph) EUDAMED
- Device Name
- ENG 4000 EUDAMED
- Model / Reference
- 80-1100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260548936506 EUDAMED
- Basic UDI-DI
- B-04260548936506 EUDAMED
- EMDN Code
- Z12120124 VIDEO/ELECTRONYSTAGMOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ENG 4000 (Electronystagmograph) by G. Heinemann Medizintechnik GmbH — Class IIa — 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-04260548936506 | Class IIa | Active |
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Manufacturer
- Manufacturer
- G. Heinemann Medizintechnik GmbH
- EUDAMED SRN
- DE-MF-000009705
Sources (1)
- EUDAMED 1700d62e-7e27-42e7-bd5d-158fd552aaea 61 fields · synced Jun 18, 2026