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Combi 4000-M (a combination of tympanometry and rhinomanometry)
EUDAMEDClass IIa (EU MDR)
Ref 80-1010
Identity
- Trade Name
- Combi 4000-M (a combination of tympanometry and rhinomanometry) EUDAMED
- Device Name
- Combi 4000-M EUDAMED
- Model / Reference
- 80-1010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260548935523 EUDAMED
- Basic UDI-DI
- B-04260548935523 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-M (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-04260548935523 | Class IIa | Active |
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Manufacturer
- Manufacturer
- G. Heinemann Medizintechnik GmbH
- EUDAMED SRN
- DE-MF-000009705
Sources (1)
- EUDAMED 6b8d19a2-6485-4ff3-94f2-b45feb44f1d3 61 fields · synced Jun 18, 2026