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Anaesthetic Mask
EUDAMEDClass IIa (EU MDR)
Ref PA150103Model PVCRef PA150100Ref PA310206Model SiliconeRef PA310204Ref PA310200Ref PA310201Ref PA150105
Identity
- Trade Name
- Anaesthetic Mask EUDAMED
- Device Name
- Anaesthetic Mask EUDAMED
- Model / Reference
- PVC EUDAMEDPA150103 EUDAMEDPA150100 EUDAMEDSilicone EUDAMEDPA310206 EUDAMEDPA310204 EUDAMEDPA310200 EUDAMEDPA310201 EUDAMEDPA150105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923310907156 EUDAMED06923310907125 EUDAMED06923310900812 EUDAMED06923310900799 EUDAMED06923310900751 EUDAMED06923310900768 EUDAMED06923310907170 EUDAMED
- Basic UDI-DI
- 69233109PA15M3 EUDAMED69233109PA31028Q EUDAMED
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS EUDAMED
Classification
- Device Class
- Class IIa 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
Anaesthetic Mask by Hangzhou Formed Medical Devices Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia face mask, single-use.
- Ventlab — Ventlab Corp. · Class I
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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 — Henan Tuoren Medical Device Co., Ltd · Class IIa
- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- King Mask — Ambu A/S · 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 | 69233109PA15M3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hangzhou Formed Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000011212
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (7)
- EUDAMED e2fe397e-f947-4fd2-9d7a-f93d5c792c14 61 fields · synced Jul 30, 2026
- EUDAMED b0078128-17fd-4263-96b4-55d4aa4ff12a 61 fields · synced May 17, 2026
- EUDAMED 94837902-453b-4cec-b73f-b2d8c88242ca 61 fields · synced May 18, 2026
- EUDAMED 8b5389b8-c482-408a-aca8-3ca9254c70fe 61 fields · synced May 18, 2026
- EUDAMED 627b47bf-2b5b-4ff1-a3bf-d7cebabb2b9a 61 fields · synced May 18, 2026
- EUDAMED 9fc48143-4445-4705-91bd-738dbeaa77d5 61 fields · synced May 18, 2026
- EUDAMED 65110b52-e1ba-42ae-8c19-567061c20111 61 fields · synced May 19, 2026