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Medical Face Mask
EUDAMEDClass I (EU MDR)
Ref TX1298-2RRef TX1295-2RRef TX1299-2Ref TX1294-2RRef TX1294-1Ref TX1299-1Ref TX1295-2Ref TX1297-1Ref TX1296-1Ref TX1298-1Ref TX1293-1Ref TX1296-2Ref TX1292-2Ref TX1292-2RRef TX1293-2Ref TX1297-2RRef TX1296-2RRef TX1294-2Ref TX1293-2RRef TX1292-1Ref TX1298-2
Identity
- Trade Name
- Medical Face Mask EUDAMED
- Device Name
- Medical Face Mask EUDAMED
- Model / Reference
- TX1298-2R EUDAMEDTX1295-2R EUDAMEDTX1299-2 EUDAMEDTX1294-2R EUDAMEDTX1294-1 EUDAMEDTX1299-1 EUDAMEDTX1295-2 EUDAMEDTX1297-1 EUDAMEDTX1296-1 EUDAMEDTX1298-1 EUDAMEDTX1293-1 EUDAMEDTX1296-2 EUDAMEDTX1292-2 EUDAMEDTX1292-2R EUDAMEDTX1293-2 EUDAMEDTX1297-2R EUDAMEDTX1296-2R EUDAMEDTX1294-2 EUDAMEDTX1293-2R EUDAMEDTX1292-1 EUDAMEDTX1298-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953102637480 EUDAMED06953102637459 EUDAMED06953102637411 EUDAMED06953102637442 EUDAMED06953102637282 EUDAMED06953102637336 EUDAMED06953102637374 EUDAMED06953102637312 EUDAMED06953102637305 EUDAMED06953102637329 EUDAMED06953102637275 EUDAMED06953102637381 EUDAMED06953102637343 EUDAMED06953102637428 EUDAMED06953102637350 EUDAMED06953102637473 EUDAMED06953102637466 EUDAMED06953102637367 EUDAMED06953102637435 EUDAMED06953102637268 EUDAMED06953102637404 EUDAMED
- Basic UDI-DI
- 69531026FMW0435ANS9H EUDAMED69531026FMW0435BNS9N EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMEDT020603 MEDICAL USE FACE MASKS, TYPE I (NOT FOR HEALTHCARE PROFESSIONALS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Medical Face Mask by Taizhou Xinkang Medical Materials 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 | 69531026FMW0435ANS9H | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Taizhou Xinkang Medical Materials Co., Ltd
- EUDAMED SRN
- CN-MF-000012941
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (21)
- EUDAMED d0b09d79-fbd5-4c56-816a-df58c8a90979 61 fields · synced Oct 6, 2026
- EUDAMED db3ec1b6-be9e-4e1f-86d8-6e3a07b55f3a 61 fields · synced May 16, 2026
- EUDAMED 1b49c5ee-db12-4976-ace2-57222ab8c0aa 61 fields · synced May 16, 2026
- EUDAMED 665d650e-f24f-4264-9e8d-1e1068987356 61 fields · synced May 16, 2026
- EUDAMED 7eaaa063-1104-4063-9ec7-4aab7da6cb08 61 fields · synced May 16, 2026
- EUDAMED 92710d96-dad6-4742-8026-cb5edf60eaac 61 fields · synced May 16, 2026
- EUDAMED 25f94156-4c61-46f7-876d-01d264fb92e0 61 fields · synced May 17, 2026
- EUDAMED b59ca5dc-3fb8-49cc-9bbc-c559cfc11340 61 fields · synced May 17, 2026
- EUDAMED 8a47f982-37eb-4581-a390-48ae7a4a47a1 61 fields · synced May 17, 2026
- EUDAMED 231ba575-db6a-4ed4-94c2-b2c2f1f842ab 61 fields · synced May 17, 2026
- EUDAMED 5e9a96ad-4d29-482d-8c8f-480aac8626a7 61 fields · synced May 17, 2026
- EUDAMED cc0446e1-6384-4e4b-912f-f9e0fd2a4d75 61 fields · synced May 17, 2026
- EUDAMED f697a133-2893-4412-b743-08e903415ea5 61 fields · synced May 17, 2026
- EUDAMED c6c4a4a7-c6a3-445b-818d-e933225b4035 61 fields · synced May 18, 2026
- EUDAMED 01b7e7e9-c6e3-4dee-b467-86f877a248a5 61 fields · synced May 18, 2026
- EUDAMED 3b59809e-ef61-47d5-ae61-2afb3ec59156 61 fields · synced May 18, 2026
- EUDAMED e65762e4-3c62-404e-a3d2-29ef39d95a50 61 fields · synced May 18, 2026
- EUDAMED e1d43b68-5612-4be6-8762-88b5af1815ed 61 fields · synced May 19, 2026
- EUDAMED 3425a3ec-c4ee-4afe-9056-6ed5c24ac0db 61 fields · synced May 19, 2026
- EUDAMED 6dbba87c-5d86-4fb4-8288-6ae3020a86af 61 fields · synced May 19, 2026
- EUDAMED ab5ccacb-1a4f-4043-8b17-58c86cef326a 61 fields · synced May 19, 2026