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Combi 4000 (a combination of tympanometry and rhinomanometry)
EUDAMEDClass IIa (EU MDR)
Ref 80-1040
Identity
- Trade Name
- Combi 4000 (a combination of tympanometry and rhinomanometry) EUDAMED
- Device Name
- Combi 4000 EUDAMED
- Model / Reference
- 80-1040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260548935554 EUDAMED
- Basic UDI-DI
- B-04260548935554 EUDAMED
- EMDN Code
- Z12149099 VARIOUS ENT INSTRUMENTS - OTHER 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
Combi 4000 (a combination of tympanometry and rhinomanometry) by G. Heinemann Medizintechnik GmbH — Class IIa — MDD — listed in EUDAMED
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-04260548935554 | Class IIa | Active |
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Manufacturer
- Manufacturer
- G. Heinemann Medizintechnik GmbH
- EUDAMED SRN
- DE-MF-000009705
Sources (1)
- EUDAMED 357f573c-7a07-491d-be42-b70b4f19213d 61 fields · synced Oct 6, 2026