← Back to catalogue
Resuscitation Mask
EUDAMEDClass I (EU MDR)
Ref TW8341NRef TW8340NRef TW8341Ref TW8343Ref TW8343NRef TW8340Ref TW8342
Identity
- Trade Name
- Resuscitation Mask EUDAMED
- Device Name
- Resuscitation Mask EUDAMED
- Model / Reference
- TW8341N EUDAMEDTW8340N EUDAMEDTW8341 EUDAMEDTW8343 EUDAMEDTW8343N EUDAMEDTW8340 EUDAMEDTW8342 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970385724058 EUDAMED06970385724041 EUDAMED06970385724089 EUDAMED06970385724034 EUDAMED06970385724072 EUDAMED06970385724003 EUDAMED06970385724027 EUDAMED
- Basic UDI-DI
- 69703857234CPR9Z EUDAMED
- EMDN Code
- R03010199 VENTILATION MASKS - OTHER 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
Resuscitation Mask by Xiamen Tianzuo Medical 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 | 69703857234CPR9Z | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xiamen Tianzuo Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000018733
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (7)
- EUDAMED 7f3ffa75-1c46-4561-9d60-b8de588444a9 61 fields · synced Aug 3, 2026
- EUDAMED a1a1f3a2-deb9-41d9-b4e8-e45c27428f4a 61 fields · synced May 11, 2026
- EUDAMED 268b711e-d4aa-47e2-9802-9b1969de7553 61 fields · synced May 16, 2026
- EUDAMED df465dad-a7ed-47a4-a3af-59f91674f5ca 61 fields · synced May 18, 2026
- EUDAMED 75cdc740-f188-4635-9b52-7e5bf5b3a944 61 fields · synced May 18, 2026
- EUDAMED 2a36c24d-ddf6-478a-9598-778f7db48c65 61 fields · synced May 18, 2026
- EUDAMED 8f96bd79-7a36-4b00-a6fd-40c29dcf6c16 61 fields · synced May 19, 2026