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Nebulizer Kit
EUDAMEDClass IIa (EU MDR)
Ref AN083000NSModel AN080000NS、 AN080001NS、 AN081000NS、 AN081001NS、 AN082000NS、 AN083000NS、 AN083001NS、 AN084000NS、 AN084001NS、 AN085000NS
Identity
- Trade Name
- Nebulizer Kit EUDAMED
- Device Name
- Nebulizer Kit EUDAMED
- Model / Reference
- AN080000NS、 AN080001NS、 AN081000NS、 AN081001NS、 AN082000NS、 AN083000NS、 AN083001NS、 AN084000NS、 AN084001NS、 AN085000NS EUDAMEDAN083000NS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09341601006772 EUDAMED
- Basic UDI-DI
- 697201396MU2ANNNNSNK001K6 EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Nebulizer Kit by Multigate 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 | 697201396MU2ANNNNSNK001K6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Multigate Co., Ltd
- EUDAMED SRN
- CN-MF-000002513
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (1)
- EUDAMED 1a395abe-f9bf-415b-b7d7-7ef230ac0bd5 61 fields · synced Jul 20, 2026