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Non-sterile nebulizer accessory kit
EUDAMEDClass IIa (EU MDR)
Ref NAK-SJ-002Ref NAK-SJ-001
Identity
- Device Name
- Non-sterile nebulizer accessory kit EUDAMED
- Model / Reference
- NAK-SJ-002 EUDAMEDNAK-SJ-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070911102 EUDAMED06975070910099 EUDAMED06975070911027 EUDAMED
- Basic UDI-DI
- 697507091NAKSM EUDAMED
- Direct Marketing DI
- 06975070911102 EUDAMED06975070910099 EUDAMED06975070911027 EUDAMED
- EMDN Code
- R03010380 AEROSOL THERAPY SYSTEMS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMEDTürkiye 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
Non-sterile nebulizer accessory kit 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 | 697507091NAKSM | 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 224edc2e-afa3-4282-9353-b9b3cd4eeec4 61 fields · synced Jul 23, 2026
- EUDAMED 5dbfa2f2-041e-4215-9129-f42df41e0815 61 fields · synced May 19, 2026
- EUDAMED e0160551-0de6-43c1-8866-cb03394eb113 61 fields · synced May 19, 2026