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CPR shield
EUDAMEDClass I (EU MDR)
Ref /Ref 1301011Ref 1301012Ref CPR-CPRef 1301001Ref SAN-0551-E-202509版
Identity
- Trade Name
- CPR shield EUDAMED
- Device Name
- CPR shield EUDAMED
- Model / Reference
- / EUDAMED1301011 EUDAMED1301012 EUDAMEDCPR-CP EUDAMED1301001 EUDAMEDSAN-0551-E-202509版 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951454728047 EUDAMED06951454782308 EUDAMED06951454790518 EUDAMED06951454784098 EUDAMED06951454755128 EUDAMED06951454760054 EUDAMED06951454731399 EUDAMED06951454786801 EUDAMED06951454783404 EUDAMED06951454717751 EUDAMED
- Basic UDI-DI
- 69514547304V6 EUDAMED
- EMDN Code
- R030199 RESPIRATORY MASKS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMEDFinland EUDAMEDAustria EUDAMEDHungary EUDAMEDIreland EUDAMEDGermany EUDAMEDNetherlands EUDAMEDSlovakia 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
CPR shield by Gauke Healthcare 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
- 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 | 69514547304V6 | Class I | Active |
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Manufacturer
- Manufacturer
- GAUKE Healthcare Co., Ltd
- EUDAMED SRN
- CN-MF-000013784
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (10)
- EUDAMED 5c2a76c2-3b18-4c54-80d0-bbcd9d33012e 61 fields · synced Aug 4, 2026
- EUDAMED 881b6b3a-68d7-49f9-9837-f41a68585368 61 fields · synced May 17, 2026
- EUDAMED 50034895-ca7d-421d-9489-b8dd82e8858d 61 fields · synced May 17, 2026
- EUDAMED 8b67ee1c-b9a4-4c36-87a7-b69422d51fe3 61 fields · synced May 17, 2026
- EUDAMED 7fc8e307-5f33-4714-9141-9cd89d39d6be 61 fields · synced May 17, 2026
- EUDAMED 1562acc9-6e73-421d-8a06-ad64e5963ee5 61 fields · synced May 17, 2026
- EUDAMED 1b941d62-d263-4103-840c-3d9b63038f15 61 fields · synced May 17, 2026
- EUDAMED d45546db-c577-485c-9140-945ffc4e639f 61 fields · synced May 18, 2026
- EUDAMED dd8161ad-66f4-4952-8875-bf31c31cd908 61 fields · synced May 18, 2026
- EUDAMED 838e83f7-0da5-499c-90de-bd37b237a858 61 fields · synced May 18, 2026