← Back to catalogue
Bigeagle
EUDAMEDClass IIa (EU MDR)
Ref NM222Model IH55Ref NB50Ref IN80Ref NU110Ref NU110ARef NM211E
Identity
- Trade Name
- Bigeagle EUDAMEDBigeagle(NM222) EUDAMED
- Device Name
- Nebulizer EUDAMED
- Model / Reference
- IH55 EUDAMEDNM222 EUDAMEDNB50 EUDAMEDIN80 EUDAMEDNU110 EUDAMEDNU110A EUDAMEDNM211E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975383560608 EUDAMED06975383560622 EUDAMED06975383560042 EUDAMED06975383560134 EUDAMED06975383560127 EUDAMED06975383560035 EUDAMED
- Basic UDI-DI
- 697538356N01ST EUDAMED
- Direct Marketing DI
- 06975383560608 EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDRomania 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
Bigeagle 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Foshan Gaunying Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000017213
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (7)
- EUDAMED ebe176d2-457e-457c-a664-e5a732b6ded6 61 fields · synced Jul 30, 2026
- EUDAMED fe4bbe66-5394-4d8f-9a59-22ef5d74dce4 61 fields · synced Jun 18, 2026
- EUDAMED 40ecd42a-bc99-48f1-bb10-752f1e11a030 61 fields · synced Jul 8, 2026
- EUDAMED ba6e71e5-b0ac-469d-a3ee-65062b10e173 61 fields · synced Jul 15, 2026
- EUDAMED 541971fc-ffd9-4981-819d-0cfc57c6d684 61 fields · synced Jul 23, 2026
- EUDAMED 387beeb8-8cdb-4118-b6dd-0a08e791b201 61 fields · synced Jul 26, 2026
- EUDAMED 84a8c366-e698-431e-82d3-35aa4eb09ffe 61 fields · synced Jul 30, 2026