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Mouth to Mouth Resuscitation Device( CPR Face Shield/Mask)
EUDAMEDClass I (EU MDR)
Ref ENCFS1CA001Ref ENCFS1CA002Ref ENCFS1BA001Ref ENMMR1AA002
Identity
- Trade Name
- Mouth to Mouth Resuscitation Device( CPR Face Shield/Mask) EUDAMEDMouth to Mouth Resuscitation Device EUDAMED
- Device Name
- Mouth to Mouth Resuscitation Device( CPR Face Shield/Mask) EUDAMEDRespiratory Mask EUDAMED
- Model / Reference
- ENCFS1CA001 EUDAMEDENCFS1CA002 EUDAMEDENCFS1BA001 EUDAMEDENMMR1AA002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942509230356 EUDAMED06942509230363 EUDAMED06942509230349 EUDAMED06974686055750 EUDAMED
- Basic UDI-DI
- 697468605CFS1CA020FJ EUDAMED697468605CFS1BA020F7 EUDAMED697468605MMR1AA020RN 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
Mouth to Mouth Resuscitation Device( CPR Face Shield/Mask) by Yiwu Ori-Power Medtech Co., Ltd. — Class I — MDR — listed in EUDAMED
Similar devices
Also classified as Anaesthesia face mask, single-use.
- Ventlab — Ventlab Corp. · Class I
- Resp-O2 Air Cushion Mask with Valve, Size #1, Neonate/Infant — Dynarex Corp. · Class I
- 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 | 697468605CFS1CA020FJ | 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 (4)
- EUDAMED 69ebfda0-6e1b-4c66-afc0-5e5976276acd 61 fields · synced Jul 21, 2026
- EUDAMED 39b9d8b6-ad90-4e41-b9fe-13af3ef07252 61 fields · synced May 17, 2026
- EUDAMED 4d025b3a-f446-45b8-8b81-7746e3fc2fed 61 fields · synced May 18, 2026
- EUDAMED 0d0217c6-c8a2-41ac-b2e2-7cb99a059512 61 fields · synced May 18, 2026