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Ecologic
EUDAMEDClass IIa (EU MDR)
Ref BR-CN195(GYEL02)Model BR-CN116Ref BR-CN171(GYV25)Ref BR-CN001(GYEL03)
Identity
- Trade Name
- ECOLOGIC EUDAMED
- Device Name
- Compressor nebulizer EUDAMED
- Model / Reference
- BR-CN116 EUDAMEDBR-CN195(GYEL02) EUDAMEDBR-CN171(GYV25) EUDAMEDBR-CN001(GYEL03) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070916275 EUDAMED06975070916268 EUDAMED06975070910143 EUDAMED
- Basic UDI-DI
- 697507091CNZN EUDAMED
- Direct Marketing DI
- 06975070916275 EUDAMED06975070916268 EUDAMED06975070910143 EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Hungary 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
Ecologic by ShenZhen Bi-rich Medical Devices 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 | 697507091CNZN | Class IIa | Active |
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Manufacturer
- Manufacturer
- ShenZhen Bi-rich Medical Devices Co., Ltd
- EUDAMED SRN
- CN-MF-000023061
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED cb93d1fc-2796-4dae-ac77-890ce2166f72 61 fields · synced Oct 6, 2026
- EUDAMED fad81651-a160-4f96-8ecb-37bb6bb0c388 61 fields · synced May 18, 2026
- EUDAMED 121ec83f-f549-4641-aaa1-c07fc3b68a8e 61 fields · synced May 18, 2026