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Nebulizer Mask Set
EUDAMEDClass I (EU MDR)
Ref NBK-1Ref NBKRef NBK-17Ref NBK13Ref NBK5Ref NBK2
Identity
- Trade Name
- Nebulizer Mask Set EUDAMED
- Device Name
- Nebulizer Mask Set EUDAMEDNebulizer Mask Set Size S GREEN EUDAMED
- Model / Reference
- NBK-1 EUDAMEDNBK EUDAMEDNBK-17 EUDAMEDNBK13 EUDAMEDNBK5 EUDAMEDNBK2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-NBK-1WX EUDAMEDNBKRG EUDAMEDNBK-17 EUDAMEDNBK-1 EUDAMEDNBK13 EUDAMEDNBK5 EUDAMEDNBK2 EUDAMED
- Basic UDI-DI
- B-NBK-1WX EUDAMED++G401NBKRG EUDAMEDB-NBK13 EUDAMEDB-NBK5 EUDAMEDB-NBK2 EUDAMED
- Direct Marketing DI
- NBKRG EUDAMEDNBK-17 EUDAMEDNBK-1 EUDAMED
- EMDN Code
- R030199 RESPIRATORY MASKS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMEDNetherlands EUDAMEDSpain 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
Category: Anaesthesia face mask, single-use
Nebulizer Mask Set by Disposafe Health & Lifecare Limited — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia face mask, single-use.
- Ventlab — Ventlab Corp. · Class I
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- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- Vital Signs™ — Airlife, Inc. · Class I
- Ventlab — Ventlab Corp. · Class I
- Anesthesia mask — Henan Tuoren Medical Device Co., Ltd · Class IIa
- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- King Mask — Ambu A/S · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-NBK-1WX | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-NBK-1WX | Class I | Active |
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Manufacturer
- Manufacturer
- Disposafe Health & Lifecare Limited
- EUDAMED SRN
- IN-MF-000020265
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (7)
- EUDAMED e64453b6-a3ca-4eec-8c50-642057bf4b04 61 fields · synced Sep 30, 2026
- EUDAMED 29fd7a28-e4a2-44bc-bf3e-f9a49da6da76 61 fields · synced May 17, 2026
- EUDAMED d9c98cca-51f0-4980-94f9-c5db6cfb5bc7 61 fields · synced May 17, 2026
- EUDAMED b9144379-da84-4466-9471-082307e78c77 61 fields · synced May 17, 2026
- EUDAMED 14562f26-f405-4323-96cb-d4f9c6a24f4c 61 fields · synced Jul 11, 2026
- EUDAMED 486ceaa9-ed3a-4d1c-95f6-6a4d5d126319 61 fields · synced Jul 25, 2026
- EUDAMED a810fb54-b183-476a-a868-b508f0103e5e 61 fields · synced Sep 30, 2026