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Single-use Medical Face Mask
EUDAMEDClass I (EU MDR)
Ref TKMFM008Model Type I with earloopRef TKMFM014Model Type IIR with earloopRef TKMFM013Model Type II with tie coverallRef TKMFM010Model Type I with earloop(fold earloop)
Identity
- Trade Name
- Single-use Medical Face Mask EUDAMED
- Device Name
- Single-use Medical Face Mask EUDAMED
- Model / Reference
- Type I with earloop EUDAMEDTKMFM008 EUDAMEDType IIR with earloop EUDAMEDTKMFM014 EUDAMEDType II with tie coverall EUDAMEDTKMFM013 EUDAMEDType I with earloop(fold earloop) EUDAMEDTKMFM010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934841516090 EUDAMED06934841516151 EUDAMED06934841516144 EUDAMED06934841516113 EUDAMED
- Basic UDI-DI
- 69348415000096Y EUDAMED69348415000156T EUDAMED69348415000146R EUDAMED69348415000116K EUDAMED
- Direct Marketing DI
- 06934841516090 EUDAMED06934841516151 EUDAMED06934841516144 EUDAMED06934841516113 EUDAMED
- EMDN Code
- T020603 MEDICAL USE FACE MASKS, TYPE I (NOT FOR HEALTHCARE PROFESSIONALS) EUDAMEDT020604 MEDICAL USE FACE MASKS, TYPE II AND IIR 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
Single-use Medical Face Mask by Anhui Tiankang 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 | 69348415000096Y | Class I | Active |
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Manufacturer
- Manufacturer
- Anhui Tiankang Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000017064
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (4)
- EUDAMED b43b07a4-15c5-4c8e-a75f-1ce3ed806a65 61 fields · synced Jul 16, 2026
- EUDAMED 799278c6-f345-4e93-90cd-4add0f14503f 61 fields · synced May 17, 2026
- EUDAMED d6a628a9-1f22-49d7-9ec0-9757848f1a99 61 fields · synced May 17, 2026
- EUDAMED 06751bdd-373d-43ce-a567-14852ccdcb3b 61 fields · synced May 17, 2026