Identity
- Trade Name
- Foil CPR Masks EUDAMED
- Device Name
- Mouth to mouth breathing mask EUDAMED
- Model / Reference
- TPS MM01 EUDAMEDTPS MM01-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977143461507 EUDAMED
- Basic UDI-DI
- 697714346TPSMM01AQ EUDAMED
- EMDN Code
- R030199 RESPIRATORY MASKS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Foil CPR Masks by Hangzhou Tuopusi Medical Products Co., Ltd — 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 | 697714346TPSMM01AQ | Class I | Active |
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Manufacturer
- Manufacturer
- Hangzhou Tuopusi Medical Products Co., Ltd
- EUDAMED SRN
- CN-MF-000039733
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED d38a14c5-3072-49b9-8a19-ce49b1168a70 61 fields · synced Jun 18, 2026