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Jazz
EUDAMEDClass IIa (EU MDR)
Ref NBM-5BModel NBM-1, NBM-2, NBM-3, NBM-4, NBM-5, NBM-6, NBM-7, NBM-8, NBM-9, NBM-10, NBM-11, NBM-3B, NBM-4B, NBM-5B, NBM-6B, NBM-7B, NBM-8B, NBM-9B
Identity
- Trade Name
- JAZZ EUDAMED
- Device Name
- Portable (Ultrasonic) Nebulizer EUDAMED
- Model / Reference
- NBM-1, NBM-2, NBM-3, NBM-4, NBM-5, NBM-6, NBM-7, NBM-8, NBM-9, NBM-10, NBM-11, NBM-3B, NBM-4B, NBM-5B, NBM-6B, NBM-7B, NBM-8B, NBM-9B EUDAMEDNBM-5B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06959989131509 EUDAMED
- Basic UDI-DI
- 69599891XZNEB0001KC EUDAMED
- Direct Marketing DI
- 06959989131509 EUDAMED
- EMDN Code
- Z12040210 ULTRASONIC NEBULISERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
Jazz by Dongguan SIMZO Electronic Technology 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 | 69599891XZNEB0001KC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dongguan SIMZO Electronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000015642
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 7e0e5273-bf34-4613-9c82-fa3977d30677 61 fields · synced Jun 19, 2026