Identity
- Trade Name
- Perfect Medical EUDAMEDPerfect Medical(NE-108) EUDAMED
- Device Name
- Nebulizer EUDAMED
- Model / Reference
- IH55 EUDAMEDNE-108 EUDAMEDPM-22 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975383560103 EUDAMED06975383560141 EUDAMED
- Basic UDI-DI
- 697538356N01ST EUDAMED
- Direct Marketing DI
- 06975383560103 EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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
Perfect Medical 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 (3)
- EUDAMED 05150761-4cc3-4b2d-9711-7ee038e41a11 61 fields · synced Sep 18, 2026
- EUDAMED f3506d67-d85f-4268-a878-3ef87c5e9ee9 61 fields · synced Jun 18, 2026
- EUDAMED 536b34a1-a652-4941-b1e4-644580d079ca 61 fields · synced Sep 18, 2026