Identity
- Trade Name
- EMSER EUDAMED
- Device Name
- IH55 (EMSER) EUDAMED
- Model / Reference
- Nebulizer EUDAMEDIH55 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975383560219 EUDAMED
- Basic UDI-DI
- B-06975383560219 EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Emser by Foshan Gaunying Electronics Co., Ltd. — 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-06975383560219 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Foshan Gaunying Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000017213
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED f6b4f9e6-62dd-4d84-8b76-ee9ab3728cd4 61 fields · synced Jul 12, 2026