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Gotze & Jensen Portable (Ultrasonic) Nebulizer
EUDAMEDClass IIa (EU MDR)
Ref NBM-4BModel 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
- Gotze & Jensen Portable (Ultrasonic) Nebulizer 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-4B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06959989131684 EUDAMED
- Basic UDI-DI
- 69599891XZNEB0001KC EUDAMED
- Direct Marketing DI
- 06959989131684 EUDAMED
- EMDN Code
- Z12040210 ULTRASONIC NEBULISERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Gotze & Jensen Portable (Ultrasonic) Nebulizer by Dongguan SIMZO Electronic Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED
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 b754044b-0a0f-4803-ac40-c4df32a7deb0 61 fields · synced Jun 18, 2026