Identity
- Trade Name
- LAICA EUDAMEDLAICA(NE1005) EUDAMED
- Device Name
- Nebulizer EUDAMED
- Model / Reference
- IH55 EUDAMEDNE1005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975383560028 EUDAMED
- Basic UDI-DI
- 697538356N01ST EUDAMED
- Direct Marketing DI
- 06975383560028 EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Laica by Foshan Gaunying Electronics Co., Ltd. — 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 | 697538356N01ST | 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 (2)
- EUDAMED 5b780049-8010-40f7-b2ef-5f6d6888dfa1 61 fields · synced Jul 22, 2026
- EUDAMED 735fa128-3e30-4c49-97a2-7c026f0ae8b8 61 fields · synced Jul 22, 2026