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nebulizer masks
EUDAMEDClass IIa (EU MDR)
Ref TKJ-NM-XLModel nebulizer masksRef TKJ-NM-LRef TKJ-NM-S
Identity
- Device Name
- nebulizer masks EUDAMED
- Model / Reference
- nebulizer masks EUDAMEDTKJ-NM-XL EUDAMEDTKJ-NM-L EUDAMEDTKJ-NM-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950921000327 EUDAMED06950921000884 EUDAMED06950921000907 EUDAMED
- Basic UDI-DI
- 69509210WHMZWF EUDAMED
- EMDN Code
- R03010301 AEROSOL THERAPY MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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 masks by Taizhou Kangjian Medical Equipments 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 | 69509210WHMZWF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Taizhou Kangjian Medical Equipments Co., Ltd.
- EUDAMED SRN
- CN-MF-000011397
- Authorised Representative
- phoenix Medtech GmbH DE-AR-000007996
Sources (3)
- EUDAMED b2623436-49cd-4053-a576-70ec7bdfe06e 61 fields · synced Oct 5, 2026
- EUDAMED 8d6c0e3f-2ab8-4723-9ae5-c458896e7909 61 fields · synced May 18, 2026
- EUDAMED 69eedea1-7220-404c-ac52-f27ccab5a1bb 61 fields · synced May 18, 2026