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Anesthesia mask
EUDAMEDClass IIa (EU MDR)
Ref SMD004Model Sillcone mask-Bending edge,Sillcone mask-Detachable type
Identity
- Device Name
- Anesthesia mask EUDAMED
- Model / Reference
- Sillcone mask-Bending edge,Sillcone mask-Detachable type EUDAMEDSMD004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16941617113909 EUDAMED
- Basic UDI-DI
- 693811937356K5 EUDAMED
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Anaesthesia face mask, single-use
Anesthesia mask by Henan Tuoren Medical Device Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia face mask, single-use.
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- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- Vital Signs™ — Airlife, Inc. · Class I
- Ventlab — Ventlab Corp. · Class I
- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- King Mask — Ambu A/S · Class I
- RUSCH — TELEFLEX INCORPORATED · Class I
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 | 693811937356K5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Henan Tuoren Medical Device Co., Ltd
- EUDAMED SRN
- CN-MF-000013924
- Authorised Representative
- MedNet EC-REP C III GmbH DE-AR-000011196
Sources (1)
- EUDAMED 581ef3c8-99d2-41c0-96da-bdd222e01ffa 61 fields · synced Jun 18, 2026