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First Aid Mask
EUDAMEDClass I (EU MDR)
Ref M80-CPR02Ref M80-CPR-ROLLRef CPR MASK
Identity
- Trade Name
- FIRST AID MASK EUDAMED
- Device Name
- FIRST AID MASK EUDAMED
- Model / Reference
- M80-CPR02 EUDAMEDM80-CPR-ROLL EUDAMEDCPR MASK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942455701276 EUDAMED06942455704994 EUDAMED06942455701283 EUDAMED
- Basic UDI-DI
- 69424557DWFAMTL EUDAMED
- EMDN Code
- R030199 RESPIRATORY MASKS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMEDFrance 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
First Aid Mask by Dragon Medical Co., Ltd — Class I — 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 | 69424557DWFAMTL | Class I | Active |
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Manufacturer
- Manufacturer
- Dragon Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000011438
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (3)
- EUDAMED ec7031cc-8648-410e-bd51-8d6f2e2761dd 61 fields · synced Jul 30, 2026
- EUDAMED 29a69cfc-6b04-4829-911a-c3f0f48b1c9d 61 fields · synced May 18, 2026
- EUDAMED b5391a95-0b7a-4d35-aff5-2a75c9038ea8 61 fields · synced May 18, 2026