Identity
- Trade Name
- Nebulizer Mask Set EUDAMED
- Device Name
- Nebulizer Mask Set EUDAMED
- Model / Reference
- NBK21 EUDAMED
Identifiers
- Primary DI / UDI-DI
- NBK21 EUDAMED
- Basic UDI-DI
- B-NBK21 EUDAMED
- EMDN Code
- R030199 RESPIRATORY MASKS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-NBK21 | 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 (1)
- EUDAMED 7e23f5d8-9684-4e15-8324-1795d29117c2 61 fields · synced Jun 18, 2026