Identity
- Trade Name
- Mouth to Mouth Mask EUDAMED
- Device Name
- CPR Mask EUDAMED
- Model / Reference
- 020# EUDAMED4105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975086430024 EUDAMED
- Basic UDI-DI
- 6975086430024BJ EUDAMED
- EMDN Code
- R030199 RESPIRATORY MASKS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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 Qingdao Ktqk Industrial Group Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Anaesthesia face mask, single-use.
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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 | 6975086430024BJ | Class I | Active |
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Manufacturer
- Manufacturer
- Qingdao Ktqk Industrial Group Limited
- EUDAMED SRN
- CN-MF-000024108
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED b0934e04-24fb-4870-be1c-a191ff93e2e6 61 fields · synced Jul 28, 2026