Identity
- Trade Name
- Face Mask EUDAMED
- Device Name
- Face Mask EUDAMED
- Model / Reference
- NE0180 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953395558356 EUDAMED
- Basic UDI-DI
- 69533955FM0020001JY EUDAMED
- 510(k) Number
- K210007 FDA 510(k)
- FDA Product Code
- FXX FDA 510(k)
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4040 FDA 510(k)
- Regulation Number
- 878.4040 FDA 510(k)
- Market of Registration
- Spain EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
This device is a Face Mask, classified under the General, Plastic Surgery advisory committee category. It is designed to provide barrier protection for the face, filtering airborne particles and reducing exposure to contaminants, pathogens, or splashes during medical or public health settings.
The Face Mask is supplied as a single-use disposable item, intended for use in clinical or non-clinical environments where respiratory or particulate protection is required. It is regulated under FDA 510(k) clearance (K210007) and MDR, with no specified MRI safety classification. Available in standard sizes, it must be stored in a clean, dry environment to maintain sterility and integrity.
Frequently asked questions
What is the primary purpose of this face mask and where can it be used?
This face mask is designed to create a barrier against airborne particles, contaminants, pathogens, and splashes, protecting both the wearer and others in shared environments. It is intended for use in clinical settings like hospitals or non-clinical environments such as public health situations where respiratory or particulate protection is needed, such as during outbreaks or high-risk exposure scenarios.
Is this face mask reusable or meant for single-use, and how should it be stored?
The face mask is explicitly labeled as a single-use disposable item, meaning it should not be reused after one application. To maintain its sterility and structural integrity, it must be stored in a clean, dry environment away from direct sunlight or moisture, ensuring it remains uncontaminated until use.
What regulatory pathways does this face mask follow, and how does that affect its use?
This device follows FDA 510(k) clearance (K210007) and MDR (Medical Device Regulation) pathways, confirming it meets U.S. and EU standards for safety and performance. The clearance indicates it is deemed substantially equivalent to a predicate device, ensuring compliance with regulatory requirements for barrier protection in medical or public health contexts. No MRI safety classification is specified, so it should not be used in MRI environments.
Are there different sizes available for this face mask, and how does that impact fit?
The device is described as available in standard sizes, though specific dimensions (e.g., small, medium, large) are not detailed. Proper fit is critical for effective barrier protection, so users should select the size that aligns with the wearer’s facial contours to minimize gaps around the nose, mouth, and chin, ensuring optimal filtration and comfort.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Jingdi Med - wound plaster, band aid, wound dressing, medical tape ..., 金华市景迪医疗用品有限公司-景迪医疗-医疗用品-浙江景迪医疗用品-金华景迪-景迪医疗用品-景迪创口贴-景迪输液贴-景迪急救包, 2026 Protective Face Mask - Jinhua Jingdi Medical Supplies Co., Ltd ..., Medical Surgical Face Mask Kids Face Mask - China Face Mask
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K210007 | Class II | Active |
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Manufacturer
- Manufacturer
- Jinhua Jingdi Medical Supplies Co., Ltd.
Sources (2)
- FDA 510(k) K210007 24 fields · synced Oct 6, 2026
- EUDAMED 207bd5b7-8184-4008-aca3-8b5081c3f917 61 fields · synced Jul 8, 2026