Identity
- Trade Name
- Irrigation handle (new) EUDAMED
- Device Name
- Irrigation handle EUDAMED
- Model / Reference
- 13-1000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04262512210322 EUDAMED
- Basic UDI-DI
- 0426251221IGHUW EUDAMED
- EMDN Code
- Q0399 ENT DEVICES - 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Irrigation handle (new) by Heinemann HNO Medizintechnik GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0426251221IGHUW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Heinemann HNO Medizintechnik GmbH
- EUDAMED SRN
- DE-MF-000046391
Sources (1)
- EUDAMED 1d888adc-2b0c-4730-bacf-7c0ed011a618 61 fields · synced Oct 7, 2026