Identity
- Trade Name
- Respiratory Mask EUDAMED
- Device Name
- Respiratory Mask EUDAMED
- Model / Reference
- ENMMR1AA001 EUDAMEDENMMR1BJ001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974686051417 EUDAMED06974686050328 EUDAMED
- Basic UDI-DI
- 697468605MMR1AA020RN EUDAMED697468605MMR1BJ020TY EUDAMED
- EMDN Code
- R030199 RESPIRATORY 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
Category: Anaesthesia face mask, single-use
Respiratory Mask by Yiwu Ori-Power Medtech Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Anaesthesia face mask, single-use.
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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 | 697468605MMR1AA020RN | Class I | Active |
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Manufacturer
- Manufacturer
- Yiwu Ori-Power Medtech Co., Ltd.
- EUDAMED SRN
- CN-MF-000021146
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 3c392279-6fde-43eb-a96e-a82b54c382d6 61 fields · synced Jul 26, 2026
- EUDAMED 3537a8e6-d3cf-46f4-abcf-b2fd2b1319ca 61 fields · synced May 18, 2026