Identity
- Device Name
- Compressor Nebulizer EUDAMED
- Model / Reference
- NB-1101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970392217130 EUDAMED
- Basic UDI-DI
- 6970392211NB0003YB EUDAMED
- Direct Marketing DI
- 06970392217130 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 — 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 | 6970392211NB0003YB | 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 (1)
- EUDAMED d74a31c3-cfc9-4f0b-ab1b-40465c7b33a2 61 fields · synced Jun 17, 2026