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Anesthesia mask
EUDAMEDClass IIa (EU MDR)
Ref IAM003Model Inflatable-Normal type，Inflatable-Soft shell type，Inflatable-Handheld type，Inflatable- Ergo maskRef SMB005Model Sillcone mask-Bending edge,Sillcone mask-Detachable typeRef SMB003Ref AMH002Ref SMB004Ref AMS002Ref AMS000Ref IAM006Ref AMS001Ref SMD003Ref AMS004Ref AMH006Ref SMB001Ref IAM001Ref AMS006Ref EM100510Model Endoscopy MaskRef IAM004Ref AMH003Ref AMS003Ref IAM002Ref AMH005Ref AME004Ref SMB002Ref IAM005Ref EM100310Ref AME005Ref IAM000Ref AMH004Ref SMB000Ref SMD004Ref AMH001Ref EM100412Ref SMD005
Identity
- Device Name
- Anesthesia mask EUDAMED
- Model / Reference
- Inflatable-Normal type，Inflatable-Soft shell type，Inflatable-Handheld type，Inflatable- Ergo mask EUDAMEDIAM003 EUDAMEDSillcone mask-Bending edge,Sillcone mask-Detachable type EUDAMEDSMB005 EUDAMEDSMB003 EUDAMEDAMH002 EUDAMEDSMB004 EUDAMEDAMS002 EUDAMEDAMS000 EUDAMEDIAM006 EUDAMEDAMS001 EUDAMEDSMD003 EUDAMEDAMS004 EUDAMEDAMH006 EUDAMEDSMB001 EUDAMEDIAM001 EUDAMEDAMS006 EUDAMEDEndoscopy Mask EUDAMEDEM100510 EUDAMEDIAM004 EUDAMEDAMH003 EUDAMEDAMS003 EUDAMEDIAM002 EUDAMEDAMH005 EUDAMEDAME004 EUDAMEDSMB002 EUDAMEDIAM005 EUDAMEDEM100310 EUDAMEDAME005 EUDAMEDIAM000 EUDAMEDAMH004 EUDAMEDSMB000 EUDAMEDSMD004 EUDAMEDAMH001 EUDAMEDEM100412 EUDAMEDSMD005 EUDAMED
Identifiers
- Primary DI / UDI-DI
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- Basic UDI-DI
- 693811937358K9 EUDAMED693811937356K5 EUDAMED693811937357K7 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
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Also classified as Anaesthesia face mask, single-use.
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- King Mask — Ambu A/S · Class I
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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 | 693811937358K9 | 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 (61)
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