Identity
- Trade Name
- Mouth to Mouth Mask EUDAMED
- Device Name
- Mouth to Mouth Mask EUDAMED
- Model / Reference
- TX1418 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953102631679 EUDAMED
- Basic UDI-DI
- 69531026MMF0508ANS5S EUDAMED
- EMDN Code
- R030199 RESPIRATORY MASKS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Category: Anaesthesia face mask, single-use
Mouth to Mouth Mask by Taizhou Xinkang Medical Materials Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69531026MMF0508ANS5S | Class I | Active |
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Manufacturer
- Manufacturer
- Taizhou Xinkang Medical Materials Co., Ltd
- EUDAMED SRN
- CN-MF-000012941
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED b9ae5afb-a735-4279-8b13-063a25b43f8d 61 fields · synced Jun 19, 2026