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Face Mask
EUDAMEDClass I (EU MDR)
Ref LEVEL 1Model Type I;Type II;Type IIR;LEVEL 1;LEVEL 2;LEVEL 3Ref Type IIRRef Type IIRef LEVEL 3Ref LEVEL 2Ref Type I
Identity
- Trade Name
- FACE MASK EUDAMED
- Device Name
- FACE MASK EUDAMED
- Model / Reference
- Type I;Type II;Type IIR;LEVEL 1;LEVEL 2;LEVEL 3 EUDAMEDLEVEL 1 EUDAMEDType IIR EUDAMEDType II EUDAMEDLEVEL 3 EUDAMEDLEVEL 2 EUDAMEDType I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978502824735 EUDAMED06978502824711 EUDAMED06978502824636 EUDAMED06978502824926 EUDAMED06978502824971 EUDAMED06978502824896 EUDAMED06978502824490 EUDAMED06978502824766 EUDAMED06978502824612 EUDAMED06978502824667 EUDAMED06978502824919 EUDAMED06978502824773 EUDAMED06978502824797 EUDAMED06978502824803 EUDAMED06978502824551 EUDAMED06978502824889 EUDAMED06978502824858 EUDAMED06978502824865 EUDAMED06978502824902 EUDAMED06978502824964 EUDAMED06978502824599 EUDAMED06978502824643 EUDAMED06978502824759 EUDAMED06978502824629 EUDAMED06975652001955 EUDAMED06978502824834 EUDAMED06978502824841 EUDAMED06978502824698 EUDAMED06978502824650 EUDAMED
- Basic UDI-DI
- 697565200FM001CT EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMEDDenmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMEDEUDAMED
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
Face Mask by Hubei Guarddent Medical Technology Co., Ltd — Class I — 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 | 697565200FM001CT | Class I | Active |
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Manufacturer
- Manufacturer
- Hubei Guarddent Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000028116
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (29)
- EUDAMED b341ca49-57fe-4611-9424-e1cda0224c46 61 fields · synced Oct 5, 2026
- EUDAMED 067553e2-bff8-4659-9136-3fd050bbb88e 61 fields · synced May 11, 2026
- EUDAMED 4670c3d0-f52b-4b40-a4fb-be332f39b2c6 61 fields · synced May 16, 2026
- EUDAMED 84a0a90a-c1b9-4d2e-9404-82252c25da4e 61 fields · synced May 16, 2026
- EUDAMED b874ff6b-fdcb-45f4-bad0-1d39844f3d3a 61 fields · synced May 16, 2026
- EUDAMED 63f6e57e-26ed-44bd-bb75-cec642579047 61 fields · synced May 17, 2026
- EUDAMED 9a5b5de9-24d9-404f-a849-25fea1a49187 61 fields · synced May 17, 2026
- EUDAMED e2995e48-214e-4733-b558-9d8aea6fa31d 61 fields · synced May 17, 2026
- EUDAMED 19e04074-be71-4198-886e-e07b55d5f265 61 fields · synced May 17, 2026
- EUDAMED edf059f5-2dd8-4216-a509-3065129d2334 61 fields · synced May 17, 2026
- EUDAMED 9a75a68c-774a-470f-a44c-446c0d8fc2d7 61 fields · synced May 17, 2026
- EUDAMED cb871170-2acd-480d-80bc-7ecd8b7d5ad5 61 fields · synced May 17, 2026
- EUDAMED 09776dbe-6168-4dce-af68-35e77350ab62 61 fields · synced May 17, 2026
- EUDAMED c3b4da77-e9b8-4bc9-89d1-e433898f6a49 61 fields · synced May 17, 2026
- EUDAMED b4f3364a-af07-4f46-a645-10f503d7cf94 61 fields · synced May 17, 2026
- EUDAMED 2bd04f6e-84fc-4e1e-87c9-e18ea2b979c1 61 fields · synced May 17, 2026
- EUDAMED a4e019a3-7793-46a5-abb9-ec796bed4b66 61 fields · synced May 17, 2026
- EUDAMED 0298bba8-a764-4d68-a48a-43b48ec8eca7 61 fields · synced May 17, 2026
- EUDAMED 54a30d5b-cced-4948-b804-fa70f13c4baa 61 fields · synced May 19, 2026
- EUDAMED c9ebed36-fa66-4405-80a8-a2426a933af1 61 fields · synced May 19, 2026
- EUDAMED bb66e164-8be9-47a9-8262-f59810ad267e 61 fields · synced May 19, 2026
- EUDAMED aca73051-c23a-41eb-8b46-abab30268bdb 61 fields · synced May 19, 2026
- EUDAMED 0395d92b-5b40-434a-89ba-c3986d22b6ab 61 fields · synced May 19, 2026
- EUDAMED 1afbc2c9-9470-40b0-a969-cf241db6a5e8 61 fields · synced May 19, 2026
- EUDAMED af24ea03-862f-4b09-be37-602ca26c7666 61 fields · synced May 19, 2026
- EUDAMED 581b65d4-c090-4421-8a66-bc45b07ba7ad 61 fields · synced May 19, 2026
- EUDAMED 5aea14f6-e339-40b5-a659-9776dd99c103 61 fields · synced May 19, 2026
- EUDAMED aaa250e1-f538-4dfd-85e2-aff739f9a263 61 fields · synced May 19, 2026
- EUDAMED 76170911-e9c5-464c-88ca-a8112a321d9c 61 fields · synced May 19, 2026