Identity
- Trade Name
- TE-OAE 4000 (otoacoustic emission) EUDAMED
- Device Name
- TE-OAE 4000 EUDAMED
- Model / Reference
- 80-1060 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260548937008 EUDAMED
- Basic UDI-DI
- B-04260548937008 EUDAMED
- EMDN Code
- Z12149001 OTOACOUSTIC EMISSIONS EQUIPMENT 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
TE-OAE 4000 (otoacoustic emission) 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-04260548937008 | Class IIa | Active |
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Manufacturer
- Manufacturer
- G. Heinemann Medizintechnik GmbH
- EUDAMED SRN
- DE-MF-000009705
Sources (1)
- EUDAMED 1d0e92bf-f319-4ea3-87a7-ddcd4d8b84e2 61 fields · synced Jun 19, 2026