Identity
- Trade Name
- ENT treatment unit MODULA Europa EUDAMED
- Device Name
- ENT treatment unit MODULA EUDAMED
- Model / Reference
- 0100-30000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260548931006 EUDAMED
- Basic UDI-DI
- 0426054893MOD3K 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
ENT treatment unit MODULA Europa by G. Heinemann 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 | 0426054893MOD3K | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- G. Heinemann Medizintechnik GmbH
- EUDAMED SRN
- DE-MF-000009705
Sources (1)
- EUDAMED a5b251e3-d44a-44f8-b7ef-7374d8878373 61 fields · synced Jul 15, 2026