Identity
- Trade Name
- Compressor Nebulizer EUDAMED
- Device Name
- Compressor Nebulizer EUDAMED
- Model / Reference
- NB-1100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942284609163 EUDAMED
- Basic UDI-DI
- 6970392211NB0007YK EUDAMED
- Direct Marketing DI
- 06942284609163 EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria 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
Compressor Nebulizer by Joytech Healthcare Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243468 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 6970392211NB0007YK | Class IIa | Active |
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Manufacturer
- Manufacturer
- JOYTECH Healthcare Co., Ltd.
- EUDAMED SRN
- CN-MF-000006020
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED f299bb7b-e3b9-424d-93d2-76b6d8ea7986 61 fields · synced Jun 19, 2026
- FDA 510(k) K243468 1 fields · synced Jun 9, 2026