← Back to catalogue
Ultrasonic Nebulisers
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref NBM-6BModel 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-9BRef NBM-1
Identity
- Trade Name
- ULTRASONIC NEBULISERS EUDAMEDAnthsania FDA UDI
- Generic Name
- Therapeutic agent nebulizer, ambulatory FDA UDI
- 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-6B EUDAMEDNBM-1 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06959989131677 EUDAMED06959989131653 EUDAMED00810021174266 FDA UDI
- Basic UDI-DI
- 69599891XZNEB0001KC EUDAMED
- Direct Marketing DI
- 06959989131677 EUDAMED06959989131653 EUDAMED
- 510(k) Number
- K230379 FDA UDI
- FDA Product Code
- CAF FDA UDI
- EMDN Code
- Z12040210 ULTRASONIC NEBULISERS EUDAMED
- GMDN Term
- Therapeutic agent nebulizer, ambulatory FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5630 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Ultrasonic Nebulisers by Dongguan SIMZO Electronic Technology Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69599891XZNEB0001KC | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dongguan SIMZO Electronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000015642
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (3)
- EUDAMED 5d79fcd5-cbc3-4e92-bcc4-cda63c31b4c5 61 fields · synced Jul 22, 2026
- EUDAMED 1730671d-9c42-4639-8c1f-3234b2d4d6d3 61 fields · synced May 19, 2026
- FDA UDI e858027c-83b8-48c5-acd5-b4c81a6a8ef3 33 fields · synced May 30, 2026